No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00085412730882 | 2C0430 | 2C0430 | Three Lead Parenteral Nutrition Transfer Set | NEP | System/device, pharmacy compounding | 2 | NA |
2 | 00085412676647 | 2R8538 | 2R8538 | CLEARLINK System Solution Set with DUO-VENT Spike | FPA | Set, Administration, Intravascular | 2 | CLEARLINK/CONTINU-FLO/DUO-VENT |
3 | 00085412639499 | 955626 | 955626 | The PrisMax control unit is a software controlled single patient device that per The PrisMax control unit is a software controlled single patient device that performs Continuous Renal Replacement Therapy and Therapeutic Plasma Exchange Therapy | KDI | Dialyzer, high permeability with or without sealed dialysate system | 2 | prisMaxPrisMax System |
4 | 00085412624839 | ADS201816 | ADS201816 | 13cm Malleable Applicator Tip | KGZ | ACCESSORIES, CATHETER | NA | |
5 | 00085412624822 | ADS201815 | ADS201815 | DISPOSABLE CURVED APPLICATOR | KYZ | SYRINGE, IRRIGATING (NON DENTAL) | NA | |
6 | 00085412025360 | 5C4527 | 5C4527 | The Short Nose Clamp for Outlet Port of Plastic Container is designed to facilit The Short Nose Clamp for Outlet Port of Plastic Container is designed to facilitate peritoneal dialysis set connector insertion into and removal from, Peritoneal Dialysis Solution in plastic container. | FKK | CLAMP, LINE | 1 | NA |
7 | 25413765545720 | 5CGM01 | 5CGM01 | Sharesource is a web-based connectivity platform that allows authorized users, i Sharesource is a web-based connectivity platform that allows authorized users, including nephrologists, clinicians, and nurses in the dialysis center, to remotely view and manage treatment information sent from the Claria APD System. | FKX | System, peritoneal, automatic delivery | 2 | Sharesource |
8 | 15413765545723 | 5CGM01 | 5CGM01 | Sharesource is a web-based connectivity platform that allows authorized users, i Sharesource is a web-based connectivity platform that allows authorized users, including nephrologists, clinicians, and nurses in the dialysis center, to remotely view and manage treatment information sent from the Claria APD System. | FKX | System, peritoneal, automatic delivery | 2 | Sharesource |
9 | 05413765482595 | H93849 | H93849 | Admix Dispensing Pin | LHI,FMF | Set, i.V. Fluid transfer,Syringe, piston | 2 | NA |
10 | 05413765404634 | 934072 | 934072 | Coseal Surgical Sealant (Coseal) is composed of two synthetic polyethylene glyco Coseal Surgical Sealant (Coseal) is composed of two synthetic polyethylene glycols (PEGs), a dilute hydrogen chloride solution and a sodium phosphate/sodium carbonate solution. These components come in a kit that includes an applicator(s). At the time of administration, the mixed PEGs and solutions form a hydrogel that adheres to tissue, synthetic graft materials and covalently bonds to itself | NBE | Sealant,Polymerizing | 3 | Coseal Surgical Sealant |
11 | 05413765404627 | 934071 | 934071 | Coseal Surgical Sealant (Coseal) is composed of two synthetic polyethylene glyco Coseal Surgical Sealant (Coseal) is composed of two synthetic polyethylene glycols (PEGs), a dilute hydrogen chloride solution and a sodium phosphate/sodium carbonate solution. These components come in a kit that includes an applicator(s). At the time of administration, the mixed PEGs and solutions form a hydrogel that adheres to tissue, synthetic graft materials and covalently bonds to itself | NBE | Sealant,Polymerizing | 3 | Coseal Surgical Sealant |
12 | 05413765404610 | 934070 | 934070 | Coseal Surgical Sealant (Coseal) is composed of two synthetic polyethylene glyco Coseal Surgical Sealant (Coseal) is composed of two synthetic polyethylene glycols (PEGs), a dilute hydrogen chloride solution and a sodium phosphate/sodium carbonate solution. These components come in a kit that includes an applicator(s). At the time of administration, the mixed PEGs and solutions form a hydrogel that adheres to tissue, synthetic graft materials and covalently bonds to itself | NBE | Sealant,Polymerizing | 3 | Coseal Surgical Sealant |
13 | 00085412639345 | 2N3358 | 2N3358 | Micro-Volume Extension Set | FPA | Set, administration, intravascular | 2 | EXTENSION SET |
14 | 00085412660387 | 2N3386 | 2N3386 | Micro-Volume Catheter Extension Set with 0.2 micrometer Filter | FPA,FPB | Set, administration, intravascular,Filter, infusion line | 2 | EXTENSION SET |
15 | 00085412653303 | 2N3383 | 2N3383 | Blood Extension Set | BRZ | Set, blood transfusion | 2 | EXTENSION SET |
16 | 00085412653297 | 2N3382 | 2N3382 | Micro-Volume Extension Set with 0.2 m Filter | FPA,FPB | Set, administration, intravascular,Filter, infusion line | 2 | EXTENSION SET |
17 | 00085412653280 | 2N3380 | 2N3380 | Micro-Volume Extension Set | FPA | Set, administration, intravascular | 2 | EXTENSION SET |
18 | 00085412639406 | 2N3363 | 2N3363 | Light Resistant Micro-Volume Extension Set | FPA | Set, administration, intravascular | 2 | EXTENSION SET |
19 | 00085412639390 | 2N3362 | 2N3362 | Polyethylene Lined Mini-Volume Extension Set | FPA | Set, administration, intravascular | 2 | EXTENSION SET |
20 | 00085412639383 | 2N3361 | 2N3361 | Polyethylene Lined Micro-Volume Extension Set | FPA | Set, administration, intravascular | 2 | EXTENSION SET |
21 | 00085412639369 | 2N3360 | 2N3360 | Polyethylene Lined Micro-Volume Extension Set | FPA | Set, administration, intravascular | 2 | EXTENSION SET |
22 | 00085412639352 | 2N3359 | 2N3359 | Mini-Volume Extension Set | FPA | Set, administration, intravascular | 2 | EXTENSION SET |
23 | 00085412639338 | 2N3357 | 2N3357 | Micro-Volume Extension Set with 0.2 Micrometer Filter | FPA,FPB | Set, administration, intravascular,Filter, infusion line | 2 | EXTENSION SET |
24 | 00085412639321 | 2N3356 | 2N3356 | Mini-Volume Extension Set | FPA | Set, administration, intravascular | 2 | EXTENSION SET |
25 | 00085412638843 | 2N3355 | 2N3355 | Mini-Volume Extension Set | FPA | Set, administration, intravascular | 2 | EXTENSION SET |
26 | 00085412638836 | 2N3354 | 2N3354 | Micro-Volume Extension Set | FPA | Set, administration, intravascular | 2 | EXTENSION SET |
27 | 00085412095165 | 1503188 | 1503188 | GELFOAM® PLUS - POWDER is an implantable hemostat supplied as a ready to use med GELFOAM® PLUS - POWDER is an implantable hemostat supplied as a ready to use medical device kit containing GELFOAM® absorbable gelatin powder, Thrombin Human lyophilized powder, two 10 mL Prefilled Saline Syringes 0.9 Percent Sodium Chloride Injection USP, and a Vial Access Device | LMF | Agent, absorbable hemostatic, collagen based | 3 | Gelfoam Plus |
28 | 00085412095158 | 1503187 | 1503187 | GELFOAM® PLUS - COMPRESSED SPONGE is an implantable hemostat supplied as a ready GELFOAM® PLUS - COMPRESSED SPONGE is an implantable hemostat supplied as a ready to use medical device kit containing GELFOAM® Compressed Sterile Sponge, Thrombin Human lyophilized powder, two 10 mL Prefilled Saline Syringes 0.9 Percent Sodium Chloride Injection USP, and a Vial Access Device | LMF | Agent, absorbable hemostatic, collagen based | 3 | Gelfoam Plus |
29 | 00085412091006 | 1502186 | 1502186 | The FLOSEAL Malleable Tip and Trimmable Tip are intended for delivery of FLOSEAL The FLOSEAL Malleable Tip and Trimmable Tip are intended for delivery of FLOSEAL Hemostatic Matrix. | LMF | Agent, Absorbable Hemostatic, Collagen Based | 3 | Floseal Special Applicator Tips |
30 | 00085412086309 | 1501341 | 1501341 | GELFOAM PLUS is an implantable hemostat supplied as a ready to use medical devic GELFOAM PLUS is an implantable hemostat supplied as a ready to use medical device kit containing GELFOAM® Sterile Sponge, Thrombin Human lyophilized powder, two 10 mL Prefilled Saline Syringes 0.9 Percent Sodium Chloride Injection USP, and a Vial Access Device | LMF | Agent, Absorbable Hemostatic, Collagen Based | 3 | Gelfoam Plus |
31 | 00085412070643 | 5C4957 | 5C4957 | UltraClamp Tubing is designed to facilitate clamping of tubing on the UltraBag C UltraClamp Tubing is designed to facilitate clamping of tubing on the UltraBag Container or any Baxter Y-Set. The clamp is specifically designed to assist individuals who experience difficulty in operating other ancillary clamps or pre-attached clamps. | FKK | CLAMP, LINE | 1 | ULTRACLAMP |
32 | 05413765586118 | ADS201897 | ADS201897 | The EASYGRIP FLO-41 Precision MIS Delivery System (EASYGRIP FLO-41 System) is a The EASYGRIP FLO-41 Precision MIS Delivery System (EASYGRIP FLO-41 System) is a sterile, single-use device that consists of two components: (1) one applicator device with a 41 cm long cannula (5 mm outer diameter) and (2) one empty 1.5 mL syringe. | GCJ | Laparoscope, general & plastic surgery | 2 | EASYGRIP FLO-41 |
33 | 00085412680743 | 2C0427 | 2C0427 | Solution Transfer Set with DUO-VENT Spike. Large Bore Tubing and Needle Adapter 26 | NEP | System/device, pharmacy compounding | 2 | SOLUTION SET |
34 | 00085412653631 | 2C8554 | 2C8554 | Male Luer Lock Adapter with Retractable Collar | FPA | Set, administration, intravascular | 2 | SOLUTION SET |
35 | 00085412639505 | 955630 | 955630 | The TherMax blood warmer is an accessory device intended for use with the PrisMa The TherMax blood warmer is an accessory device intended for use with the PrisMax system and appropriate blood warmer compatible Prismaflex sets for the therapy in use. The blood warmer heats the return blood flow during a PrisMax system treatment in order to replace heat lost to the atmosphere and replacement fluids. | KDI | Dialyzer, high permeability with or without sealed dialysate system | 2 | therMaxTherMax Blood Warmer |
36 | 00085412565705 | 2R8864 | 2R8864 | Non-DEHP BURETROL Solution Set, 150 mL Burette Drip Chamber Filter Valve, 3 Luer Non-DEHP BURETROL Solution Set, 150 mL Burette Drip Chamber Filter Valve, 3 Luer Activated Valves, Male Luer Lock Adapter with Retractable Collar | FPA | Set, administration, intravascular | 2 | CLEARLINK/BURETROL |
37 | 07332414123932 | 955516 | 955516 | The Blood Warmer Disposable is a disposable circuit for use with the TherMax blo The Blood Warmer Disposable is a disposable circuit for use with the TherMax blood warmer in combination with other PrisMax disposable sets. | KDI | Dialyzer, high permeability with or without sealed dialysate system | 2 | therMaxTherMax Blood Warmer |
38 | 00085412827957 | ADS202105 | ADS202105 | Floseal with Recothrom - 5mL | PMX | Absorbable collagen hemostatic agent with thrombin | FLOSEAL HEMOSTATIC MATRIX | |
39 | 00085412656304 | ADS201883 | ADS201883 | Floseal Matrix is indicated in surgical procedures (other than in ophthalmic) as Floseal Matrix is indicated in surgical procedures (other than in ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical. | PMX | Absorbable collagen hemostatic agent with thrombin | 3 | FLOSEAL HEMOSTATIC MATRIX |
40 | 00085412639604 | ADS201845 | ADS201845 | FLOSEAL Hemostatic Matrix, 10mL | PMX | Absorbable collagen hemostatic agent with thrombin | 3 | FLOSEAL HEMOSTATIC MATRIX |
41 | 00085412639598 | ADS201844 | ADS201844 | FLOSEAL Hemostatic Matrix, 5ml | PMX | Absorbable collagen hemostatic agent with thrombin | 3 | FLOSEAL HEMOSTATIC MATRIX |
42 | 00085412532868 | 1505291 | 1505291 | FLOSEAL Hemostatic Matrix, 10 mL | PMX | Absorbable collagen hemostatic agent with thrombin | 3 | Floseal |
43 | 00085412532738 | 1505288 | 1505288 | FLOSEAL Hemostatic Matrix, 5 mL | PMX | Absorbable collagen hemostatic agent with thrombin | 3 | Floseal |
44 | 00085412083322 | 934033 | 934033 | The COSEAL Applicator is used for mixing and delivery of the two COSEAL Surgical The COSEAL Applicator is used for mixing and delivery of the two COSEAL Surgical Sealant Components. | NBE | Sealant,Polymerizing | 3 | Coseal Surgical Sealant Replacement Applicator |
45 | 00085412050829 | 5C4136 | 5C4136 | This adapter consists of a spike connector, approx. 10.15 cm (4 inch) long, 3.81 This adapter consists of a spike connector, approx. 10.15 cm (4 inch) long, 3.81 mm (0.150 inch) ID tubing and a flanged Easy-Lock Connector. This device is indicated for the personal cycler peritoneal dialysis system used for automatic control of dialysate solution exchanges in the treatment of renal failure patients undergoing peritoneal dialysis. | FKX | System, peritoneal, automatic delivery | 2 | Easy-Lock |
46 | 05413765577369 | 83003393 | 83003393 | ABACUS 3.3 ME | NEP | SYSTEM/DEVICE, PHARMACY COMPOUNDING | 2 | ABACUS |
47 | 05413765577352 | 83003392 | 83003392 | ABACUS 3.3 SE | NEP | SYSTEM/DEVICE, PHARMACY COMPOUNDING | 2 | ABACUS |
48 | 05413765577345 | 83003391 | 83003391 | ABACUS 3.3 CE | NEP | SYSTEM/DEVICE, PHARMACY COMPOUNDING | 2 | ABACUS |
49 | 05413765577321 | 83003390 | 83003390 | ABACUS 3.3 DE | NEP | SYSTEM/DEVICE, PHARMACY COMPOUNDING | 2 | ABACUS |
50 | 00085412722894 | 5C4145NS | 5C4145NS | The 15L Cycler Drainage Bag is not sterile product and is intended to serve as a The 15L Cycler Drainage Bag is not sterile product and is intended to serve as a container or device to collect (effluent) peritoneal cavity drainage from the drain line on Baxter Automated Peritoneal Dialysis (APD) Cycler Tubing Sets. | KDJ | Set, Administration, For Peritoneal Dialysis, Disposable | Cycler Drainage Bag |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00085412087788 | 0600021 | 0600021 | Spray set consisting of: 2 Spray Heads 1 dual-lumen connection tube consisting o Spray set consisting of: 2 Spray Heads 1 dual-lumen connection tube consisting of a pressure line with a transparent sterile filter, and a thinner sensing line with a blue sterile filter and an EASYSPRAY-Clip to be attached to the COSEAL Surgical Sealant plunger for gas activation. | Coseal Spray Set | BAXTER INTERNATIONAL INC. |
2 | 00085412083339 | 934034 | 934034 | The COSEAL Applicator is used for mixing and delivery of the two COSEAL Surgical The COSEAL Applicator is used for mixing and delivery of the two COSEAL Surgical Sealant Components. | Coseal Surgical Sealant Extended Applicator | BAXTER HEALTHCARE CORPORATION |
3 | 00085412083322 | 934033 | 934033 | The COSEAL Applicator is used for mixing and delivery of the two COSEAL Surgical The COSEAL Applicator is used for mixing and delivery of the two COSEAL Surgical Sealant Components. | Coseal Surgical Sealant Replacement Applicator | BAXTER HEALTHCARE CORPORATION |
4 | 10801741099370 | TDST0020 | TDST0020 | Tridyne Vascular Sealant Standard Spray Tips | Tridyne™ Vascular Sealant Standard Spray Tips | NEOMEND, INC. |
5 | 10801741010030 | PGST009 | PGST009 | Progel Applicator Spray Tips | Progel™ Applicator Spray Tips | NEOMEND, INC. |
6 | 10705031133105 | 4901 | 4901 | ETHICON OMNEX | ETHICON INC. | |
7 | 05413765583605 | ADS201810 | ADS201810 | Preveleak Surgical sealant is a sealant developed to seal suture holes formed du Preveleak Surgical sealant is a sealant developed to seal suture holes formed during surgical repair of the circulatory system and to reinforce sutured anastomoses. | PREVELEAK SURGICAL SEALANT | BAXTER HEALTHCARE CORPORATION |
8 | 05413765583599 | ADS201809 | ADS201809 | Preveleak Surgical sealant is a sealant developed to seal suture holes formed du Preveleak Surgical sealant is a sealant developed to seal suture holes formed during surgical repair of the circulatory system and to reinforce sutured anastomoses. | PREVELEAK SURGICAL SEALANT | BAXTER HEALTHCARE CORPORATION |
9 | 05413765583582 | ADS201808 | ADS201808 | Preveleak Surgical sealant is a sealant developed to seal suture holes formed du Preveleak Surgical sealant is a sealant developed to seal suture holes formed during surgical repair of the circulatory system and to reinforce sutured anastomoses | PREVELEAK SURGICAL SEALANT | BAXTER HEALTHCARE CORPORATION |
10 | 05413765583520 | ADS201807 | ADS201807 | The delivery tip (10 pack) is a sterile, non-pyrogenic, single-use accessory dev The delivery tip (10 pack) is a sterile, non-pyrogenic, single-use accessory device for use with the PREVELEAK family of products. | PREVELEAK SURGICAL SEALANT | BAXTER HEALTHCARE CORPORATION |
11 | 05413765583414 | 1514243 | 1514243 | Spray set consisting of: 2 Spray Heads 1 dual-lumen connection tube consisting o Spray set consisting of: 2 Spray Heads 1 dual-lumen connection tube consisting of a pressure line with a transparent sterile filter, and a thinner sensing line with a blue sterile filter and an EASYSPRAY-Clip to be attached to the COSEAL Surgical Sealant plunger for gas activation. | COSEAL SPRAY SET | BAXTER HEALTHCARE CORPORATION |
12 | 05413765404634 | 934072 | 934072 | Coseal Surgical Sealant (Coseal) is composed of two synthetic polyethylene glyco Coseal Surgical Sealant (Coseal) is composed of two synthetic polyethylene glycols (PEGs), a dilute hydrogen chloride solution and a sodium phosphate/sodium carbonate solution. These components come in a kit that includes an applicator(s). At the time of administration, the mixed PEGs and solutions form a hydrogel that adheres to tissue, synthetic graft materials and covalently bonds to itself | Coseal Surgical Sealant | BAXTER HEALTHCARE CORPORATION |
13 | 05413765404627 | 934071 | 934071 | Coseal Surgical Sealant (Coseal) is composed of two synthetic polyethylene glyco Coseal Surgical Sealant (Coseal) is composed of two synthetic polyethylene glycols (PEGs), a dilute hydrogen chloride solution and a sodium phosphate/sodium carbonate solution. These components come in a kit that includes an applicator(s). At the time of administration, the mixed PEGs and solutions form a hydrogel that adheres to tissue, synthetic graft materials and covalently bonds to itself | Coseal Surgical Sealant | BAXTER HEALTHCARE CORPORATION |
14 | 05413765404610 | 934070 | 934070 | Coseal Surgical Sealant (Coseal) is composed of two synthetic polyethylene glyco Coseal Surgical Sealant (Coseal) is composed of two synthetic polyethylene glycols (PEGs), a dilute hydrogen chloride solution and a sodium phosphate/sodium carbonate solution. These components come in a kit that includes an applicator(s). At the time of administration, the mixed PEGs and solutions form a hydrogel that adheres to tissue, synthetic graft materials and covalently bonds to itself | Coseal Surgical Sealant | BAXTER HEALTHCARE CORPORATION |
15 | 00850868002063 | 2.5 ml | 9007 | PreveLeak™ Surgical Sealant (PreveLeak™) is a sealant developed to seal surface PreveLeak™ Surgical Sealant (PreveLeak™) is a sealant developed to seal surface holes formed during surgical repair of the circulatory system and to reinforce sutured anastomoses. When applied, PreveLeak™ creates an elastic biocompatible gel that seals suture holes or gaps formed between synthetic grafts or patches and native vessel anastomosis. PreveLeak™ adheres to the native tissues as well as synthetic materials, including PTFE and Dacron grafts, and facilitates sealing along anastomotic closure lines. After application, PreveLeak™ is a natural golden color and stays soft and flexible. Animal studies showed the majority of PreveLeak™ is largely resorbed by 12 months. PreveLeak™ is provided in a double-barreled syringe assembly containing equal volumes of purified bovine serum albumin (BSA) and polyaldehyde. PreveLeak™ is supplied in a double pouch, with two delivery tips and terminally sterilized. PreveLeak™ is ready to use once the pouch is opened, the syringe cap removed, the delivery tip is attached and the tip is primed. When the plunger is depressed, the two components are thoroughly mixed as they pass through the delivery tip. After applications, the sealant is allowed to remain undisturbed for at least 60 seconds before unclamping and exposing the anastomosis to arterial pressure. PreveLeak™ is applied as a viscous liquid that gels within approximately 10-15 seconds. PreveLeak™ is terminally sterilized by e-beam irradiation and is provided in a double pouch with two delivery tips. Additional sterile delivery tips are available separately. PreveLeak™ is provided for single-use only. | PreveLeak™ Surgical Sealant | TENAXIS MEDICAL, INC. |
16 | 00850868002056 | 10 pack Tips | 8003 | Accessory tips for PreveLeak™ Surgical Sealant | PreveLeak™ 10 pack Tips | TENAXIS MEDICAL, INC. |
17 | 00850868002049 | 2.5 ml | 9007 | PreveLeak™ Surgical Sealant (PreveLeak™) is a sealant developed to seal surface PreveLeak™ Surgical Sealant (PreveLeak™) is a sealant developed to seal surface holes formed during surgical repair of the circulatory system and to reinforce sutured anastomoses. When applied, PreveLeak™ creates an elastic biocompatible gel that seals suture holes or gaps formed between synthetic grafts or patches and native vessel anastomosis. PreveLeak™ adheres to the native tissues as well as synthetic materials, including PTFE and Dacron grafts, and facilitates sealing along anastomotic closure lines. After application, PreveLeak™ is a natural golden color and stays soft and flexible. Animal studies showed the majority of PreveLeak™ is largely resorbed by 12 months. PreveLeak™ is provided in a double-barreled syringe assembly containing equal volumes of purified bovine serum albumin (BSA) and polyaldehyde. PreveLeak™ is supplied in a double pouch, with two delivery tips and terminally sterilized. PreveLeak™ is ready to use once the pouch is opened, the syringe cap removed, the delivery tip is attached and the tip is primed. When the plunger is depressed, the two components are thoroughly mixed as they pass through the delivery tip. After applications, the sealant is allowed to remain undisturbed for at least 60 seconds before unclamping and exposing the anastomosis to arterial pressure. PreveLeak™ is applied as a viscous liquid that gels within approximately 10-15 seconds. PreveLeak™ is terminally sterilized by e-beam irradiation and is provided in a double pouch with two delivery tips. Additional sterile delivery tips are available separately. PreveLeak™ is provided for single-use only. | PreveLeak™ Surgical Sealant | TENAXIS MEDICAL, INC. |
18 | 00850868002032 | 5 ml | 9008 | PreveLeak™ Surgical Sealant (PreveLeak™) is a sealant developed to seal surface PreveLeak™ Surgical Sealant (PreveLeak™) is a sealant developed to seal surface holes formed during surgical repair of the circulatory system and to reinforce sutured anastomoses. When applied, PreveLeak™ creates an elastic biocompatible gel that seals suture holes or gaps formed between synthetic grafts or patches and native vessel anastomosis. PreveLeak™ adheres to the native tissues as well as synthetic materials, including PTFE and Dacron grafts, and facilitates sealing along anastomotic closure lines. After application, PreveLeak™ is a natural golden color and stays soft and flexible. Animal studies showed the majority of PreveLeak™ is largely resorbed by 12 months. PreveLeak™ is provided in a double-barreled syringe assembly containing equal volumes of purified bovine serum albumin (BSA) and polyaldehyde. PreveLeak™ is supplied in a double pouch, with two delivery tips and terminally sterilized. PreveLeak™ is ready to use once the pouch is opened, the syringe cap removed, the delivery tip is attached and the tip is primed. When the plunger is depressed, the two components are thoroughly mixed as they pass through the delivery tip. After applications, the sealant is allowed to remain undisturbed for at least 60 seconds before unclamping and exposing the anastomosis to arterial pressure. PreveLeak™ is applied as a viscous liquid that gels within approximately 10-15 seconds. PreveLeak™ is terminally sterilized by e-beam irradiation and is provided in a double pouch with two delivery tips. Additional sterile delivery tips are available separately. PreveLeak™ is provided for single-use only. | PreveLeak™ Surgical Sealant | TENAXIS MEDICAL, INC. |
19 | 00850868002025 | 4 ml | 9004 | PreveLeak™ Surgical Sealant (PreveLeak™) is a sealant developed to seal surface PreveLeak™ Surgical Sealant (PreveLeak™) is a sealant developed to seal surface holes formed during surgical repair of the circulatory system and to reinforce sutured anastomoses. When applied, PreveLeak™ creates an elastic biocompatible gel that seals suture holes or gaps formed between synthetic grafts or patches and native vessel anastomosis. PreveLeak™ adheres to the native tissues as well as synthetic materials, including PTFE and Dacron grafts, and facilitates sealing along anastomotic closure lines. After application, PreveLeak™ is a natural golden color and stays soft and flexible. Animal studies showed the majority of PreveLeak™ is largely resorbed by 12 months. PreveLeak™ is provided in a double-barreled syringe assembly containing equal volumes of purified bovine serum albumin (BSA) and polyaldehyde. PreveLeak™ is supplied in a double pouch, with two delivery tips and terminally sterilized. PreveLeak™ is ready to use once the pouch is opened, the syringe cap removed, the delivery tip is attached and the tip is primed. When the plunger is depressed, the two components are thoroughly mixed as they pass through the delivery tip. After applications, the sealant is allowed to remain undisturbed for at least 60 seconds before unclamping and exposing the anastomosis to arterial pressure. PreveLeak™ is applied as a viscous liquid that gels within approximately 10-15 seconds. PreveLeak™ is terminally sterilized by e-beam irradiation and is provided in a double pouch with two delivery tips. Additional sterile delivery tips are available separately. PreveLeak™ is provided for single-use only. | PreveLeak™ Surgical Sealant | TENAXIS MEDICAL, INC. |
20 | 00801741099380 | TDET0006 | TDET0006 | Tridyne Vascular Extended Tips, 6” | Tridyne™ Vascular Sealant Extended Spray Tips | NEOMEND, INC. |
21 | 00801741099366 | TDVS004 | TDVS004 | Tridyne Vascular Sealant | Tridyne™ Vascular Sealant | NEOMEND, INC. |
22 | 00801741010026 | PGPS002 | PGPS002 | Progel Pleural Air Leak Sealant | Progel™ Pleural Air Leak Sealant | NEOMEND, INC. |
23 | 00801741010019 | PGEN005-11 | PGEN005-11 | Progel Extended Applicator Spray Tip | Progel™Extended Applicator Spray Tip | NEOMEND, INC. |
24 | 00801741010002 | PGEN005-06 | PGEN005-06 | Progel Extended Applicator Spray Tip | Progel™Extended Applicator Spray Tip | NEOMEND, INC. |