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E-Bid For Rate Contract Cum Supply And Empanelment Of Surgical And Suture Items-1 Anti A Blood Grouping Serum IP(Anti A Monoclonal Serum) [225] 2 Anti B Blood Grouping Serum IP(Anti B Mono Clonal Serum) [226] 3 Anti D(Rh) Blood Grouping Serum IP/Anti D Blood Grouping Serum IP [227] 4 VDRL Antigen (with +ve and -ve control) / RPR slide Kit :- Specification for RPR _Rapid plasma regain) slide test for detection of regain antibodies in syphilis1. Rapid Plasma Reagin test kit having Non- treponemal Cardiolipin antigen coated carbon particles used in the detection of regain antibodies in serum / plasma of suspected cases of Syphilis by the flocculation reaction.2. The kit should be meant for qualitative and semi quantitative detection of regain antiboidies against the Non-treponemal Cardiolipin antigen.3. Sensitivity & specificity should be 95% or more.4. Positive & negative control serum should be provided with the kit for at least 10% of the tests in each kit.5. The kit should have shelf life of minimum 12 months or more at the time of delivery of consignment. The kit should be stored at 2° C - 8° C.6. Adequate literature detailing the principle, Components, methodologies, Validity criteria. Bio-safety, performance characteristics, storage conditions, limitation of assay, manufacture and expiry dates and methods of disposal should be provided with each kit.7. The test should be free from possible interferences with potentially cross reactive sera.8. All the test kits should be provided with necessary / required disposable accessories in sufficient quantity.9. The imported kit should have approval of the statutory authority in its country of origin . The imported kits should have been registered and licensed in India by the CDSCO. (Central drugs standard control organization) 5 Double Blood Bags with SAGM (350ml)General Specifications Annexure- XVI and Specification in Annexure-XXIII 6 Laproscopic Knotless PGA -PCL Bidirectional taper point Surgical Suture Self fixation device with autolock mechanism made up of PGA -PCL Bidirectional taper point 17 mm & 32cm 7 Curved cutter stapler 40 mm linear cutter simultaneous cutting and stapling 8 AORTIC PUNCH 4.5 Length betwwen 6 to 7 Midlength Diamond edge sharp, dual cut edge for clean precise removal of aortic tissue, conical tip or round / eliptical tip for easy insertation by straight or button hole tech, should have long and short handle confirguaration, sterile packing 9 AORTIC PUNCH 3.6 Length betwwen 6 to 7 Midlength Diamond edge sharp, dual cut edge for clean precise removal of aortic tissue,conical tip or round / eliptical tip for easy insertation by straight or button hole tech, should have long and short handle confirguaration, sterile packing 10 Biopsy Gun with compatible Co-axial needle 14g X 11cm to 20cm Programmable automatic should have 20mm sample notch and thin wall cannula for larger core and echogenic making on both stylet tip and cannula for improved visibility during procedure. Should have three programmable firing mode-Automatic mode, Delay mode and Zero throw mode. Should have two firing btton on surface of the gun, Size 12G, 14G, 16G, 18G, 20G with length 11cm, 15cm, 20cm. Should come with compatible coaxial packed with Biopsy Gun. USFDA Approved. 11 Programmable automatic biopsy Gun with compatible Co-axial needle Size 18gX11cm or above Should have 20mm sample notch and thin wall cannula for larger core and echogenic making on both stylet tip and cannula for improved visibility during procedure. Should have three programmable firing mode-Automatic mode, Delay mode and Zero throw mode. Should have two firing btton on surface of the gun, Size 12G, 14G, 16G, 18G, 20G with length 11cm, 15cm, 20cm. Should come with compatible coaxial packed with Biopsy Gun. USFDA Approved. (Size 18gX11cm or above) 12 Programmable automatic biopsy Gun with compatible Co-axial needle Size 18gX15cm or above Should have 20mm sample notch and thin wall cannula for larger core and echogenic making on both stylet tip and cannula for improved visibility during procedure. Should have three programmable firing mode-Automatic mode, Delay mode and Zero throw mode. Should have two firing button on surface of the gun, Size 12G, 14G, 16G, 18G, 20G with length 11cm, 15cm, 20cm. Should come with compatible coaxial packed with Biopsy Gun. USFDA Approved. (Size 18gX15cm or above) 13 Long term double lumen dialysis catheter Size- 15Fr X 27 cm Long term double lumen dialysis catheter with kit accessories should be provided catheter, pull apart sheath, dialator, tunnelling stylet, guide wire j/s, with dispenser and injection Caps, symmetrical tip retrograde and antigrade Size- 15Fr X 27 cm USFDA certification along with ISO, CE 14 Closed Suction Catheter Has Isolated turbo cleaning chamber for cleaning catheter tip.Catheter is made up of medical grade Silicon Material,Catheter has Zig-Zag Ports for better suctioning. Twin PEEP seals. Available in Both Endotracheal and Tracheostomy Version.Can be used for 72hr. 15 Sulu Stepped Cartridges for variable tissue application , fixed anvil , different leg length staples in same cartridge , inbuilt knife ,size 60 mm inner to outer side 3.0,3.5 and 4.0 mm , purple colour code, USFDA Approved 10mm 16 Flexometlic Tube 3-8.5 with stylet Reinforce ET Tube with wiring from tip to end it should be approved by *US FDA 17 Disposable transducers for invasive pressure monitoring•Should be compatible with available system in Cath Lab and ICCU at SMSH• Should meet highest medical industrial standards• Quality certification should be provided form authorized agencies.US FDA + CE/ DGCI APPROVED•(IABP – Data Scope & Cath Lab transducer) 18 Absorbable Surgical Suture (Sterile Catgut),BP/USP Needled Suture Chromic (l/2 Cir RB Needle 20mm Length 76 cm) Size-3/0 19 Absorbable Surgical Suture (Sterile Catgut), BP/USP Needled Suture Chromic (l/2 Cir RB Needle 40mm Length 76 cm) Size-1/0 20 Absorbable Surgical Suture (Sterile Catgut),BP/USP Needled Suture Chromic (1/2 Cir RB Needle 45 mm Length 100 cm) Size-1 21 NON ABSORBABLE SURGICAL SUTURE, STERILISED SURGICAL NEEDLED SUTURE POLYAMIDE MONOFILAMENT BLACK (NYLON) (3/8 Cir slim blade Cutting Needle 15mm Length 70 cm)Size 5/0 22 Non absorbable surgical suture sterilized surgical needled suture Polybutylate / Silicon Coated with Polyster Braided (Green / Blue) *with 1/2 Circle Taper cut , 25mm Double armed Needle, Suture Length of 90cm with pledgets Size 6 X 3 X l.5mmSize 2/0 23 Sterile Disposable (Single Use) Teflon / PTFE I.V. Cannula with integrated 3 Way stop cock. Size 16G• Should be packed in transparent, single blister pack.• As per IS 10555 standard 24 Surgical Blade Sterile, Size 11• Single peel pack in metal foil• The tip of the blade shall be well defined, central and sharp. There shall be no waviness, jags, feathers, nicks, or other defects on the cutting edge. The surfaces of the blade shall be smooth and free from tool marks and any sign of corrosion. • As Per IS 3319(BIS Mandatory) 25 Surgical Blade Sterile, Size 15• Single peel pack in metal foil• The tip of the blade shall be well defined, central and sharp. There shall be no waviness, jags, feathers, nicks, or other defects on the cutting edge. The surfaces of the blade shall be smooth and free from tool marks and any sign of corrosion. • As Per IS 3319(BIS Mandatory) 26 Standard PMMA Intra Ocular Lenses (Size + 18 D to + 24 D)• 6mm optic size 12.5 - 13.0 mm total diameter, Biconvex1. PMMA optics and haptics single piece with hole2. 6mm optic size 12.5 to 13mm total diameter, Biconvex3. IOL haptics – modified C shaped with 5° -10° anterior angulation.4. Should have 360° square edges.5. IOL should have UV blocking capability6. Diopters- + 18 D to + 24 D at 0.5 D step.7. Supplying unit should be ISO accredited and IOL should be CE/US FDA certified. 27 Umbilical Catheter (for New Born) All sizes• Radio opaque line• With female flexible mount• Colour coded connector• Open tip should be soft, rounded, atraumatic• Length 40 cm 28 Eye pressure shield Should be made up of Soft Foam and Rigid Plastic Shield, Length of 178 to 185 mm and width of 83 to 88mm, Foam Thickness of 17 to 19mm. Plastic Type Triton TX-2001, Enough holes on Nasal rib and either side of the shield to prevent condensation, Weight not more than 50gms, CE Certified. 29 Chemotherapy Port &Non-coring needles(Adult)• Valved catheter need only saline flush, catheter with intermediate size port with small septum and silicon filled suture holes, should be MRI compatible with cathlock radio-opaque ring. 8FR with silicon material with peel apart percutaneous introducer system.• Chemo port huber needle 20g and 22g. 30 Chemotherapy Port &Non-coring needles(Pediatric)• catheter need only saline flush, catheter with intermediate size power port with large septum and silicon filled suture holes, should be MRI compatible with cathlock radio-opaque ring. 6FR with silicon material with peel apart percutaneous introducer system• Chemo port huber needle 20g and 22g. 31 NON ABSORBABLE SURGICAL SUTURE, STERILISED SURGICAL NEEDLED SUTURE BRAIDED COATED POLYSTER,GREEN/WHITE or BLUE/WHITE Coated Polyster Braided (Green / Blue) with 1/2 Circle Tapercut Double Needle 25mm, Suture Length 90 cm size 3/0 32 Light weight monofilament polypropylene mesh, Design to confirm inguinal anatomy, 3D shape Size large Left 10.8*16cm /15*10 cm 33 Light weight monofilament polypropylene mesh, Design to confirm inguinal anatomy, 3D shape Size large Right 10.8*16cm /15*10 cm 34 Light weight monofilament polypropylene mesh, Design to confirm inguinal anatomy, 3D shape Size extra large Left 12.4cm * 17.3* /16*12 cm 35 Light weight monofilament polypropylene mesh, Design to confirm inguinal anatomy, 3D shape Size extra large Right 12.4cm * 17.3*/16*12 cm 36 Disposable laparoscopic Clip Applier Preloaded with 15/16 clips, 5mm diameter with Clip logic technology and digital display Titanium Clips- U shaped 37 Synthetic oxidised re-generated cellulose double layered with PEG and Trilysine size 2*4cm or size 2-3*5-6cm 38 Ionic silver highly absorbent multilayer foam dressing with broad spectrum antimicrobial , bactericidal efficacies and having a soft siliconadhesive wound contact layer , providing sustain release of Silver upto 7 days. Size: 10 Cms x 10 Cms and more 39 Self-Adherent Moist Wound foam Dressing made up of Multilayer Matrix with soft silicon adhesive layer for Pressure Ulcers/Bed Sores at Sacrum 16 Cms x 20 Cms and more 40 Double/Single wall Resuscitator with PEEP valve in Adult (Double wall Resuscitator with PEEP valve in Adult It should be fully autoclavable double wall with hand strap It should be supplied with Autoclavable/ETO reservoir bag It should have a single shutter valve system made of silicone rubber It should have Easy attachment of PEEP valve for Adult Bag Volume: Mark IV (1300 ml or more) Weight: Adult (415 g) and more It should be US-FDA, CE & ISO certified Adult 41 Pediatric Nasal Cannula Pediatric Nasal Cannula Softech with Universal Oxygen Connector, 7 Star-Lumen Tubing Lightweight, flexible nasal cannula with standard over-the-ear designed that optimizes fit and stability, Soft nasal prongs help maximize patient comfort. Individually packaged for convenience and sterility. Manufacturer must be USFDA registered / certified with EN/EU ISO 13485 / applicable 510K & CE certification. 42 Elongated Aerosol Mask Adult Elongated Aerosol Mask Adult with Under-the-chin design for excellent fit on wide range of face sizes must be Clear, soft vinyl for patient comfort; Adjustable nose clip assures comfortable fit; Specifically designed for aerosol therapy; must be with supplied with 6ft -7ft. Corr A Flex Corrugated Tubing, featuring cuttable sections every 6 in. Manufacturer must be US-FDA registered & certified with EN/EU ISO 13485 & applicable 510K & CE certification. 43 Infant Prong CPAP cannula Infant Prong CPAP cannula Nasal Size 0 with designed to reduce trauma associated with delivery of infant nasal CPAP. Must be Soft siliconised, anatomically curved prongs to enhance fit. Luer fitting on expiratory connector to allow proximal airway pressure monitoring. Each set to include, Soft Siliconised Cannula; Inspiratory & Expiratory elbow connector; Knit cap; Two 6 in. hook and loop fastener sections; Two 10 to 7.5 mm adaptors. Manufacturer must be USFDA registered / certified with EN/EU ISO 13485 / applicable 510K & CE certification. 44 H10ydrophilic Wire Long Length Hrophilic guidewire of .018, .025, .035, .038 in 150-180cm length with straight, angled tip. Should come in stiff & standard configuration, nitinol core polyurethane jacket hydrophilic coated guide wires with radiopaque jacket for enhanced visibility, hydrated gel coating and true 1:1 torque. USFDA Approved. 45 Hydrophilic Wire Long Length Hydrophilic guidewire of .018, .025, .035, .038 in 220-260cm length with straight, angled tip. Should come in stiff & standard configuration, nitinol core polyurethane jacket hydrophilic coated guide wires with radiopaque jacket for enhanced visibility, hydrated gel coating and true 1:1 torque. USFDA Approved. 46 Hydrophillic Braided Sheath Hydrophilic Braided Sheath Introducer in 4F to 7F, Length: 7cm, 10-11cm, 15-16cm, 23-25cm Or 7-25 cm with the option of .018, .021, .025 plastic jacketed and spring coil guidewire. Should have ultra-thin wall and flat wire braiding technology to provide support and low profile.USFDA Approved 47 Femoral Sheath with Needle Femoral sheath in 5F to 8F, Length: 11-25cm with puncher needle of 18g and guidewire of .035, .038. Should have rotating suture ring, snap-fit dilator to prevent slipping during insertion and holster pack. Should be available in polypropylene. USFDA Approved 48 Closed Suction Catheter for Paediatrics Number and color- coded graduations for controlled depth suctioning. Separate Y connectors available for different tubes in the pack. Catheter is made up of medical grade Silicon/ Poly Urethane Material. sizes 8fr. USFDA/ Notified CE approved 49 Closed Suction Catheter for Paediatrics Number and color- coded graduations for controlled depth suctioning.S eparate Y connectors available for different tubes in the pack. Catheter is made up of medical grade Silicon/ Poly Urethane Material. sizes are 10fr. USFDA/ Notified CE approved 50 Closed Suction Catheter for Paediatrics Number and color- coded graduations for controlled depth suctioning. Separate Y connectors available for different tubes in the pack. Catheter is made up of medical grade Silicon/ Poly Urethane Material. sizes 12fr. USFDA/ Notified CE approved 51 Closed Suction Catheter MDI Port has isolated cleaning chamber for cleaning catheter tip with MDI port. Catheter is made up of medical grade Silicon/Poly Urethane material, Catheter has ZigZag Ports for better suctioning. Available in Both Endotracheal and Tracheostomy Version. Can be used for 72hr. Size 12-Fr Product should be USFDA approved 52 Closed Suction Catheter Has Isolated Cleaning Chamber 12 Fr. Closed Suction Catheter Has Isolated turbo cleaning chamber for cleaning catheter tip.Catheter is made up of medical grade Silicon/ Poly Urethane Material,Catheter has Zig-Zag Ports for better suctioning. Available in Both Endotracheal and Tracheostomy Version.Can be used for 72hr. Size 12 Fr. 53 Closed Suction Catheter MDI Port has isolated cleaning chamber for cleaning catheter tip with MDI port. Catheter is made up of medical grade Silicon/Poly Urethane material, Catheter has ZigZag Ports for better suctioning. Available in Both Endotracheal and Tracheostomy Version. Can be used for 72hr. Size 14-Fr Product should be USFDA approved. 54 Central line with Triple Lumen with Y Needle with syringe and Guide Wire 7fr to 8.5fr With 15 cm to 20 cm Catheter With Tecoflex/ Polyurathane Material with USFDA approved. 55 Sterile Self adherent with Lipido colloid technology / safetac layer sterile self -adherent patented TLC matrix (lipido colloid technology) wound contact layer combined with absorbent polyurethane foam pad, a superabsorbent layer, a vapour permeable waterproof outer film with soft silicone adhesive border on the edges for atraumatic removal and repositioning of dressing. Size 13x13 cm and more 56 Sterile Self adherent with Lipido colloid technology / safetac layer sterile self -adherent patented TLC matrix (lipido colloid technology) wound contact layer combined with absorbent polyurethane foam pad, a superabsorbent layer, a vapour permeable waterproof outer film with soft silicone adhesive border on the edges for atraumatic removal and repositioning of dressing. Size 10x25 cm 57 Polysiloxane or Silicone Gel sheet for scar management. size 10 * 10 cm or 10x18cm
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