Medical consumables

Опис на набавката

1 Central venous catheterization set consisting of: a three-lumen catheter made of biocompatible polyurethane with a soft atraumatic tip, size 7F, lumens 16G /18G /18G, diameter 2.4mm and length 20cm, with proximal, central and distal opening in the lower part; marked for X-rays, a flexible guide wire, made of nitinol, with a length of 50cm and a diameter of 0.89mm, resistant to bending, with a J tip and one straight tip for better direction change during insertion, needle-free anti-air and antibacterial safety valves on each of the lumens, to ensure a closed system when disconnecting a syringe or infusion line and preventing air embolism; side channel with stopper with injection membrane, introducer needle 18 G with a length of 70mm, Seldinger type; integrated and easily movable fixation, dilator, transparent dispenser, scalpel 11 E, syringe 5ml with screw, ECG connecting cable
2 Antimicrobial set of three-lumen central venous catheter according to the Seldinger method. The set consists of: a catheter with lumen sizes 16/18/18G, made of smooth, transparent, radiopaque polyurethane, graduated, marked lumen, with an atraumatic 'blueflex tip' catheter tip, with flexible suture wings, with the option that the lumens can be used for separate administration of incompatible drugs, with different lengths of extension lines, with a connector for both lumens, 7F, length 20cm, impregnated with bactericidal and fungicidal protection (chlorhexidine acetate and silver sulfadiazine) along the entire length of the catheter and ports PUR AGB PLUS. Stainless steel guide wire 0.032'' with a length of 60cm ECG marked. Seldinger needle 18G/6.35cm, 5ml standard Luer slip syringe, clamp and port clamp.
3 Set for a three-lumen central venous catheter according to the Seldinger method to consist of: a catheter with a thickness of 7F, 3-lumens 16G/18G/18G, length 20cm, made of smooth, transparent, radiopaque polyurethane, graduated, with a marked lumen, with an atraumatic catheter tip, 'blueflex tip', which does not irritate and reduces the risk of perforation of blood vessels, with flexible suture wings, there should be an option for the lumens to be used for separate administration of incompatible drugs, with different lengths of extension lines. Guide wire with a thickness of 0.81mm and a length of 60cm. Introducer needle should be 18G x 6.35cm, Seldinger introducer 18G x 6.4cm and Raulersin syringe 5ml. The set should be sterile for single use.
4 Three-lumen central venous catheter consisting of: luer lock and ABS valve, with curved polyurethane extension tube and central round polycarbonate hub, polycarbonate catheter with soft tip, guide wire with advancer and smooth surface, 0.018”- 0.035” diameter with J tip and two soft ends, syringe, 18 Ga straight and Y introducer needle with valve, dilator, injection cap, injection needle and fastener. To have FDA and SFDA certification or equivalent. Dimension 7 Fr , 20cm ( +/- 5%)
5 Hydrophilic set for transfemoral access, 10cm, 4-9F RO along the entire length with hemostatic valve and Side tube introducer with anti-kink layer, dilator, wire 45cm, 0.038" metal needle 18G 7cm or equivalent
6 Disposable Hi-flow Oxygen Therapy System consisting of: 1. Heated inspiratory breathing circuit consisting of: Heated inspiratory hose consisting of three connections for connecting a temperature probe so that the hose can be heated, one connection of the hose to be located at one end, while the other connection at the opposite end, as well as the connection for the adapter from the heater; Humidification chamber compatible with an active humidifier; Shorter breathing hose used when the set is connected to a ventilator; O2 hose required when using the set with an O2 blender; Clip/clip for positioning the hose on a pillow or blanket for prevention while sleeping.
2. Nasal cannula with a hose that connects and is compatible with the inspiratory heating hose, made of soft silicone prongs that will not cause decubitus ulcers on the patient's nasal mucosa and a clamp for attaching to the patient's head. The nasal cannula hose should be flexible and can be rotated on both the left and right sides of the patient, depending on which side the humidifier, blender or ventilator will be placed. The hose should be made of breathable material, which allows for minimizing condensation in it. The hose should also have a hose holder that helps prevent the hose itself from falling off while the patient is sleeping.
7 Thermal ECG paper, Z-fold, dimensions 210 x 295, 100 sheets, compatible with the Edan SE 1202 device
8 Capillary blood glucose strips
9 Thoracic drain, sterile, with RTG marker, graduated made of high-quality medical plastic, length 50cm, sterile double medical packaging, upper part foil, lower part paper PE-PAPER POUCH, sizes 24FG-30FG
10 Abdominal drain, quality medical plastic, X-ray line, depth markers 8-26 centimeters from the tip, rounded distal tip, two lateral openings 60 centimeters long, sterile double medical packaging, upper part foil, lower part paper - PE/Paper Pouch, sizes 30 FG - 34 FG
11 Disposable Venturi O2 mask with fixed valve, size M/L, to have elastic for attaching to the head, inhalation tube, humidification cap, fixed valve, oxygen connection tube. The valve should have markings for adjusting the oxygen flow, from 24-50%, with 24% of the oxygen concentration fulfilling a flow volume of 3L/min, while 50% of the oxygen concentration fulfilling a flow volume of 15L/min. To have a maximum pressure (Pmax) of 200kPa.
12 Nebulizer masks with polyisoprene valve, with PVC aerosol mask, hose length 210cm, with nebulizer volume of 6ml, flow rate of 8LPM and nebulizer flow of 0.34ml/min. To be disposable, in sterile individual packaging. (with tolerance +/-3%)
13 Surgical caps for EU - to be made of non-woven textile; with elastic band/thread to accommodate the shape of the head.

Опис на набавката

14 Disposable surgical masks - made of non-woven hypoallergenic textile, with nose clip, tie-on or elastic, minimum two-layer
15 Galosh - PVC or non-woven fabric
16 Oronasal mask for non-invasive ventilation in sizes M, L, XL for multiple use, with a standard elbow without exhalation holes. To have a basic pressure value <30hPa, and a dead space volume of 190ml to 215ml depending on the size of the mask (For size M, the dead space volume should be 190ml, for size L, 210ml and for size XL, 215ml). The flow resistance should be for 100L/min – 0.1hPa. The mask should have a soft silicone cushion filled with silicone gel, in order to avoid decubitus ulcers. To be combined with an adjustable ring on the standard elbow that allows flexibility and can be rotated (turned) for easier adjustment to the patient's face. To have unique magnetic clips for easier and faster fixation and removal of the mask. The mask shall also have clamps for attaching the mask to the patient's head. The mask shall be capable of being thermally disinfected in a disinfector using a hot steam procedure at 90 - 93°C for 10 minutes or manually using a manual disinfection procedure with a recommended hand disinfectant
17 Neutral electrode with an effective contact area of 85 cm2 (permissible deviation +/-10%) and a ring with an area of 23 cm2 (permissible deviation +/-10%), compatible with the connection cable for the neutral plate for the VIO3 ERBE electrosurgical generator or equivalent, intended for use regardless of the type of surgical procedure, to be made of flexible material that can adapt to any body shape, to be intended for use in adult patients.
18 Nelaton catheter 6,8,10Fr
19 Aluminum intubation stylet coated with soft plastic or silicone with dimension 10-12Fr with plastic end, which should be soft atraumatic and silicone, without aluminum.
20 Foley catheter 2-channel, to be made of latex and coated on the outside and inside with abrasion-resistant silicone, to have a valve for luer and luerlock syringe. To be sterile for single use, drainage period min. 4 weeks,, balloon of 5-10ml, atraumatic tip and 2 lateral openings, with a length of 40cm (+-5% tolerance), Ch 16-30.
21 Self-adhesive antimicrobial incision foil with iodoform for the operating field, with dimensions 45cm x 66cm, incision surface dimensions 56cm x 45cm, sterilization with Gamma rays. (deviation in dimensions +-/5%).
22 Adhesive foil for mechanical removal of dirt from footwear in medical rooms with dimensions 115cm length and 45cm width, (with a tolerance of +/-10%).
23 Self-adhesive polyurethane foam sacrum dressing of 5 layers: a layer with a silicone mesh for rapid absorption of exudate, a layer with absorbent polyurethane foam, a layer with non-woven textile for exudate distribution and a layer with a superabsorbent core of polymer fibers and a protective waterproof layer with dimensions 23 x 23cm, cushion dimensions of 17 x 16.5cm (with a tolerance of +/-7%)
24 Thin hydrocolloid dressing for the prevention and treatment of decubitus, made of multilayer hydrocolloid with pectin, maximum up to 1mm thickness and dimensions 15x15 cm +/-5%
25 Double-channel foil catheter, made of latex, coated with a thin layer of silicone-siliconized, with a length of 40cm, packed in double sterile packaging (with a permissible deviation of +/-5%) of 14 Fr
26 Double-channel foil catheter, made of latex, coated with a thin layer of silicone-siliconized, with a length of 40cm, packed in double sterile packaging (with a tolerance of +/-5%) of 16 Fr
27 Double-channel foil catheter, made of latex, coated with a thin layer of silicone-siliconized, with a length of 40cm, packed in double sterile packaging (with a tolerance of +/-5%) of 18 Fr
28 Double-channel foil catheter, made of latex, coated with a thin layer of silicone-siliconized, with a length of 40cm, packed in double sterile packaging (with a tolerance of +/-5%) of 20 Fr
29 Universal connector hose made of transparent plastic, with a length of 200-300cm, size 32Fr
30 Jankauer set 30 Fr for single use, sterile, consisting of a double-ended hose with connectors for an aspirator (handle) and a suction machine with a length of 200 – 300cm and an aspirator (handle) made of hard transparent plastic; curved at an angle of 40 - 50 degrees, with a vacuum control opening and with one end compatible with the hose connector and the other end in the form of a crown with lateral openings
31 Drain with vacuum container of 18Fr, volume minimum 400ml, drain to be made of polyvinyl chloride, minimum length of drain 70cm (with a tolerance of +/-10%)
32 Endotracheal tube with cuff, made of polyvinyl chloride, latex-free, sterile, non-pyrogenic, for single use 7.0mm
33 Endotracheal tube with cuff, made of polyvinyl chloride, latex-free, sterile, non-pyrogenic, for single use 7.5mm
34 Endotracheal tube with cuff, made of polyvinyl chloride, latex-free, sterile, non-pyrogenic, for single use 8.0mm
35 Endotracheal tube with cuff, made of polyvinyl chloride, latex-free, sterile, non-pyrogenic, for single use 8.5mm
36 Nasogastric tube of 14Fr., made of polyvinyl chloride, minimum length 115cm (with a tolerance of +/- 10%)
37 Nasogastric tube 16Fr., made of polyvinyl chloride, minimum length 115cm (with a tolerance of +/- 10%)
38 Nasogastric tube 18Fr., made of polyvinyl chloride, minimum length 115cm (with a tolerance of +/- 10%)
39 Respirator hose set consisting of a connector with luer lock or equivalent, Y connector, 2 hoses with dimensions of 1.6-1.8m and two cups for draining the ends of the hoses, made of PVC material, for single use.
40 Respiratory hose set for anesthesia machine consisting of a connector with luer lock closure or equivalent, Y connector, 2 hoses of 1.8m and an auxiliary hose of 1.5cm and min. 2 liters of balloon, made of PVC material, for single use; (with a permissible deviation of +/-5%) in length.

Опис на набавката

41 Endomyocardial biopsy forceps, radiopaque, made of steel (SSt), with the possibility of flexible and non-flexible steel shaft with and without FEP coating, polyetherimide sliding body and handles: 2 steel symmetrical activation forks in the distal part for cutting the sample, to be activated using a plastic handle of three rings, of which the central one to be rotating, confirmed torque (torqueability); three types of curvature: straight, pre-curved and maxi-curved. The length should be from 50cm to 150cm. The outer diameter of the fork should be from 1.5, 1.8, 2.2 and 2.4mm; 5-7.5Fr; min. 4 types of biopsy sample volume from min. 1.8mm3 to 5.43mm3.
42 Thoracic and pleural drainage set - thin puncture needle 3.35mm x 78mm (with a tolerance of +/- 10%), catheter 2.7 x 450mm (with a tolerance of +/- 10%) - pcs. 1; anti-reflux valves - pcs. 2; 1.5-2 liter bags - pcs. 1; three-piece syringe 50-60ml - pcs. 1; three-way diverter - pcs. 1; bag with composition PP/PE-com.1
43 "CO2 absorption system compatible with Dräger anesthesia machines or equivalent: The system consists of a disposable canister filled with CO2 absorber in the form of hemispherical pellets in a semicircular shape with a diameter of 2 to 4 mm and composition: calcium hydroxide, sodium hydroxide, ethyl violet and water. This shape does not allow the formation of channel zones, which allows for uniform and efficient absorption of CO2. The granules should not be subject to abrasion, which would prevent the appearance of dust particles that, if formed, are harmful to high-tech anesthesia equipment. The granules should change color gradually to visually show the use and need to replace the canister. The canister should have an absorber capacity of at least 1200 ml and, using an adapter, be easily connected to the anesthesia machine by pressing a button. The closed system provides protection for personnel who in this way will not have direct contact with the absorber and are not exposed to dust and toxic substances. The canister can be replaced at any time, even during surgery, where a non-return valve closes the breathing system until a new canister is installed, so as not to affect the parameters of the device. "
44 Titanium clips for ligation of blood vessels S(small)-3.6mm, the cartridge shall be adhesive and shall contain 9 clips. The clip shall have a pyramidal shape and the titanium wire shall be triangular shaped for precise positioning.
45 Titanium clips for ligation of blood vessels S(small)-4.7mm, the cartridge shall be adhesive and shall contain 9 clips. The clip shall have a pyramidal shape and the titanium wire shall be triangular shaped for precise positioning.
46 Titanium clips for ligation of blood vessels-M(medium)-5.6mm, the cartridge shall be adhesive and shall contain 9 clips. The clip shall have a pyramidal shape and the titanium wire shall be triangular in shape for precise positioning.
47 Single-lumen percutaneous venous and pulmonary artery access set MAC, polyurethane, with haemostatic valve and blocking obturator, cathgard or equivalent, guide J type, sheath 8.5Fr/10cm, possibility of introducing a 7-7.5Fr catheter, guide 45cm/0.89mm, needle 6.35cm/18G., (with a permissible length deviation of +/- 10%), but not in diameter
48 Tracheostomy tube set made of thermosensitive PVC with cuff, with two color-coded inner cannulas, outer diameter 10mm and length 70mm, cuff diameter 21mm, obturator, neck fixator, water-soluble gel lubricant. Size 7;7.5;8;8.5;9;9.5
49 Endobronchial double-lumen tube set consisting of: a tube with two polyurethane cuffs proximal to the trachea and distal to the bronchus (colored for easy identification with a bronchoscope) and a stylet (mandrel) for intubation; 2L adaptable connectors with a section for the entry of an aspiration catheter that has a closure option, 2 aspiration catheters and one Y connector; with dimensions 35Fr, 37Fr, 39Fr; left
50 Adult sensor with two emitters and one receiver compatible with Invos rSO2 monitor or equivalent
51 HEPA filter with mechanical filtration method for single max. 24 hour use in red with high retention rate for prophylaxis against bacteria and viruses, for protection of anesthesia and respiratory machines with bacterial retention of 99.9999% and viral retention of 99.9999%, dead space of 55ml with recommended tidal volume of 300 to 1500ml and resistance of ˂2 for 30L/min, and ˂4 for 60L/min with diameter not greater than 69mm., weight up to 40g and to penetrate liquids up to 96mbar. To have excellent humidification performance to support and protect lung ventilation.
52 "Mechanical HEPA filter for maximum seven-day use with a high degree of retention for the prophylaxis of bacterial and viral infections, compatible with Dräger aspirator with bacterial retention of 99.99997%, viral retention of 99.99922%, NaCl retention of 99.8900% and 100% fluid and aerosol retention. To be with a maximum capacity of 90ml, made of polystyrene in the form of a cup and with a filtration method mechanical and hydrophobic (HEPA) or equivalent. Submission of data that the retention of the filter has been passed in accordance with the rules of an appropriate laboratory. "
53 Disposable HME filter (heat and moisture exchange) for respirator, with electrostatic filtration method, and dead space volume maximum 55ml, luer lock connection with which the opening is attached to the filter itself, with bacterial retention 99.99%, viral retention 99.9%, filter resistance of maximum 1.3 mbar at a flow of 30L/min, moisture loss maximum 9.4 mgH2O/L air (Vt 500 ml), maximum time of need for one patient 24h.

Опис на набавката

54 Arterial catheterization set according to Seldinger II SAC (Seldinger arterial catheterization), the set should contain: flexible curved wings with low profile with a suture hole, integral extension, biocompatible hydrophilic polyurethane catheter with hydrophilic coating, needle with low friction during injection; with clear colored border for arterial access, J tip guide /straight type, with dimensions catheter 18G/23cm, guide 60cm/0.64mm, needle 7cm/18G
55 Hepa filter with guard, class 13, knitted with the possibility of warming and humidification, with efficiency ˃99.99999 for bacteria, ˃99.9999 for viruses, effective for HIV and Hepatitis C, with a weight of max. 38g. Moisture loss up to 9Vt 500 and moisture output 28Vt 500, resistance 2.8 at 60L/min. With machine connector 22Fr.
56 Oxygen masks for adults, soft-touch, flexible, without the possibility of kinking and adjustable nose clip, with adjustable nose clip and elastic, hose to be 200-210cm long. The mask and tube shall be made of high-quality medical grade plastic, latex-free, in sterile
individual packaging.
57 Thermodilution catheter set for jugular and femoral application 7Fr The set shall contain: proximal lumen port 29cm (with a tolerance of +/-5%), catheter length 110cm (with a tolerance of +/-5%), thermodilution catheter with a maximum balloon of 1.5cm and an inflation diameter of 12mm (with a tolerance of +/-5%), control syringe, extension lines, 4 channels, long distal lumen for visualization of the wave, clear color code and labeled extension lines, with sterile protection along the entire length and integrated flushing/balloon test chamber.
58 Effective respiratory therapy by maintaining maximum inspiration with a wide flow rate of 600-1200 ml/sec., 3 colors of balls in 3 chambers, hose length 28cm, mouthpiece length 6.5cm (with a tolerance of +/-5%). Minimum flow rate printed on each chamber, for single use.
59 Patient cable, atrial for connecting wires/electrodes for temporary cardiac electrical stimulation to an external pacemaker 5392 (Medtronic), reusable with a minimum length of 180cm, or equivalent
60 Patient cable, ventricular for connecting wires/electrodes for temporary cardiac electrical stimulation to an external pacemaker 5392 (Medtronic), reusable with a minimum length of 180cm, or equivalent
61 Aid for better visualization of the surgical field, removes blood through irrigation with a fine mist of physiological solution, does not allow drying and dehydration of sensitive tissue
62 Retrograde cannula made of PVC with auto-inflate cuff made of polyurethane with pressure monitoring line, solid stylet, integrated stopcock and special handle, size 15F; length 31.8 cm, with permissible length deviations of +/-5%
63 "Two-chamber thoracic drainage with a total capacity of D110 (1350ml + 1150 ml), - The first chamber to be divided into two subchambers - the first subchamber to be graduated in increments of 1ml up to a capacity of 100ml and in increments of 2ml for a capacity of 100ml to 200ml; the second subchamber to be graduated in increments of 10ml up to a capacity of 1350ml - The second chamber to be graduated in increments of 10ml up to a capacity of 1150ml - Suction control from -5 to -25 cmH20 - Maximum negative pressure of -60 cmH20 - Dimensions of the thoracic drainage without hoses: 270x76x360 mm (WxDxH) - Two hoses for connection to the drainage - The chamber shall be equipped with a place for taking a sample of the drained fluid - With a “slide clamp” for manual release of high negative intrathoracic pressure which simultaneously allows tightening of the hose for connection to the drainage, closing the vacuum source and opening the outlet for air intake into the chamber for collection of drained fluid - Ability to use as gravitational and controlled suction - With connection to the vacuum source - With connection to the catheter with anti-clink sheath and universal connector - Integrated transport handle - Hooks for positioning on the patient's bed - Positive pressure valve - Suction control button "
64 Ambu Resuscitation Set for multiple use for adult patients, to be composed of an Ambu breathing bag made of reusable silicone, not less than 1500ml, with a handle, to contain a safety valve for regulating the flow 40+/-10mbar/cmH2O, to contain a plastic oxygen hose 2m long, to contain a silicone oxygen mask for multiple use size 5, the set to be placed in a transparent plastic case, the Ambu bag and the mask to be autoclavable at a temperature of up to 134 degrees Celsius
65 Humidifier jar for a reusable flowmeter compatible with a flowmeter from the manufacturer Dräger or equivalent, the humidifier jar to have a capacity of 100ml with a thread for connecting the flowmeter of M 34 x 1.5, the jar to be sterilized at 134 degrees Celsius
66 Reusable test lung compatible with V-family respirators from the manufacturer Dräger or equivalent, to be made of carbon fiber, silicone, polysulfone, which are strong enough to withstand the test of time while ensuring consistent performance of the respirator, test lung to weigh no more than 190 grams, excluding the carbon fiber cover, to be sterilizable at 134 degrees
67 Reusable flow sensor compatible with V-family respirators from the manufacturer Dräger or equivalent, the sensor to be composed of measuring wires, pins for fixing the measuring wires, a cuvette and a connector with a pinch, the cuvette to be made of polycarbonate material, and the part where the sensor is inserted from acrylonitrile-butadiene-styrene with a platinum wire of 13 micrometers, the principle of measurement anemometry to be using hot wire, the operating life of the probe sensor shall be as long as a successful calibration can be achieved, it shall be disinfectable and reusable, the flow sensor shall meet the requirements of ISO 80601-2-13

Опис на набавката

68 Reusable inspiratory valve compatible with Dräger V-family respirators or equivalent. All parts of the inspiratory valve shall be sterilizable at 134 degrees.
69 Disposable HiFlow hose cable as a temperature adapter, yellow, for controlling the heated air in the hose
70 Disposable HiFlow hose cable as a temperature heater, blue, for heating the air through the hoses for HiFlow therapy
71 Nebulizer for aerosol therapy of drugs compatible with Dräger breathing machines or equivalent. Nebulizer hose to be supplied with the nebulizer
72 Manometer with 0-200 bar scale for bottle compatible with Dräger ALDUK IV or equivalent
73 Gasket for Dräger ALDUK IV, rubber with metal ring compatible with pressure gauge for bottle ALDUK IV or equivalent
74 Sterile, three-way luer-lock valves for pressure infusion diversion and monitoring, color coded (red/white/blue), 360° rotatable, resistant to lipids, leaks, contamination and air embolism, PVC and latex free
75 High-range cartridges for measuring blood clotting time during open heart surgery; during cardiac and vascular interventions; compatible with ACT Plus device or equivalent
76 Sterile polyurethane arterial catheter for Seldinger technique, length 8-10cm, available from 0.6-1.2 F, with puncture needle and guidewire, with sterile latex-free adhesive tape that allows simple, fast and safe fixation without suturing
77 Plastic male/female stopper compatible with intravenous cannulas/infusion lines/catheters, sterile, single use, latex and PVC-free
78 "ELECTRODES (self-adhesive pads) Adult electrode pads (pre-connected) compatible with SCHILLER DG5000/DG4000 defibrillator or equivalent, electrodes to be compatible without adapter, and packaging to have a diagram for electrode placement"

Список и краток опис на правилата и критериумите

For registered applicants - Decision to place a medical device on the market or temporary or permanent parallel import permit, in accordance with the Law on Medicines and Medical Devices.
For unregistered applicants - Import permit (intervention import permit) in accordance with the Law on Medicines and Medical Devices or a Certificate issued by MALMED, confirming that if they are selected in the procedure, they will be issued an import permit.

Список и краток опис на правилата и критериумите

Document for registered activity as proof that it had been registered as a natural person or legal entity to perform the activity related to the subject of the contract for public procurement; or proof that it belongs to a suitable association pursuant to the regulations of the country where it has been registered.
Certificate for wholesale of medical devices pursuant to the Law on Medicines and Medical Devices.