No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00811137010769 | 4R2422 | 4R2422 | Red Cell Freezing Pack 2000 mL. Sterile Fluid Path | KSR | Container, Empty, For Collection & Processing Of Blood & Blood Components | NA | |
2 | 00811137010714 | 4C2468 | 4C2468 | SEPACELL Pre-Storage Leukocyte Reduction Set for Red Cells. Sterile Fluid Path | CAK | Microfilter, Blood Transfusion | 2 | NA |
3 | 00811137010691 | 4C2223 | 4C2223 | Blood Component Infusion Set- Standard Blood Component Filter Female Luer. Steri Blood Component Infusion Set- Standard Blood Component Filter Female Luer. Sterile Fluid Path | BRZ | Set, Blood Transfusion | 2 | NA |
4 | 00811137010462 | 4C2300 | 4C2300 | SEPACELL Pre-Storage Leukocyte Reduction Set for Red Cells. Sterile Fluid Path | CAK | Microfilter, Blood Transfusion | NA | |
5 | 00811137010455 | 4C2160 | 4C2160 | Blood Component Recipient Set with Standard Blood Filter with Luer Adapter. Ster Blood Component Recipient Set with Standard Blood Filter with Luer Adapter. Sterile Fluid Path | BRZ | Set, Blood Transfusion | 2 | NA |
6 | 00811137010431 | 4C4502 | 4C4502 | Sepacell PLD-10ALeukocyte Reduction Y-Administration Set. Sterile Fluid Path | CAK | Microfilter, Blood Transfusion | 2 | NA |
7 | 00811137010400 | 4C2161 | 4C2161 | Y-Type Blood component Recipient Set with Standard Blood Filter and Luer Adapter Y-Type Blood component Recipient Set with Standard Blood Filter and Luer Adapter. Sterile Fluid Path | BRZ | Set, Blood Transfusion | 2 | NA |
8 | 10811137010704 | 4C2243 | 4C2243 | Plasma Transfer Sets with Two Spikes. Sterile Fluid Path | KSB | Set, Transfer (Blood/Plasma) | NA | |
9 | 10811137010650 | 4C2240 | 4C2240 | Plasma Transfer Sets with Spike and Male Luer Adapter. Sterile Fluid Path | KSB | Set, Transfer (Blood/Plasma) | NA | |
10 | 00811137012695 | 4C2498H | 4C2498H | Y-Type Connector Set with Luer Lock | KSB | Set, Transfer (Blood/Plasma) | 2 | NA |
11 | 00811137013050 | 2.2 | 5S9804 | Fenwal DXT Relay is a Microsoft Windows-based software application intended to b Fenwal DXT Relay is a Microsoft Windows-based software application intended to be used by trained blood center professionals to receive and transmit data between blood bank instruments (apheresis and nonapheresis) and computer systems. The data may also be stored in and accessed from Fenwal DXT Relay’s database | MMH,OUG | Blood Establishment Computer Software And Accessories,Medical Device Data System | 1 | Fenwal DXT Relay |
12 | 00811137012992 | 4R5742 | 4R5742 | For Collection of Two Leukoreduced Red Blood Cell Products by Centrifugation. Fo For Collection of Two Leukoreduced Red Blood Cell Products by Centrifugation. For Use with the ALYX System. Sterile Fluid Path. | GKT | Separator, Automated, Blood Cell, Diagnostic | ALYX 2RBC LR Kit with Saline Spike | |
13 | 00811137012411 | 4R2441 | 4R2441 | Apheresis Needle with MASTERGUARD Protector 17 Ga. x 1-1/4'' BE. Sterile Fluid Path. | FIE | Needle, Fistula | 2 | Apheresis Needle with MASTERGUARD Protector |
14 | 00811137012435 | 4R2440 | 4R2440 | Apheresis Needle with MASTERGUARD™ Protector 16 Ga. x 1-1/4'' BE (Back Eye). Ste Apheresis Needle with MASTERGUARD™ Protector 16 Ga. x 1-1/4'' BE (Back Eye). Sterile Fluid Path. | FIE | Needle, Fistula | Apheresis Needle with MASTERGUARD™ Protector | |
15 | 00811137010127 | 4R5720 | 4R5720 | For Collection of Two Leukoreduced Red Blood Cell Products by Centrifugation. Fo For Collection of Two Leukoreduced Red Blood Cell Products by Centrifugation. For Use With the ALYX™ System. Sterile Fluid Path. | GKT | Separator, Automated, Blood Cell, Diagnostic | 2 | ALYX™ 2RBC-LR Kit |
16 | 00811137012916 | 4R5730 | 4R5730 | For Collection of Plasma Product by Centrifugation. For Use With the ALYX System For Collection of Plasma Product by Centrifugation. For Use With the ALYX System. Sterile Fluid Path. | GKT | Separator, Automated, Blood Cell, Diagnostic | ALYX Plasma Kit | |
17 | 00811137010738 | 4R2027 | 4R2027 | Transfer Pack Container 600 mL with 8 couplers. Sterile Fluid Path | KSR | Container, Empty, For Collection & Processing Of Blood & Blood Components | Transfer Pack | |
18 | 10811137010636 | 4R2023 | 4R2023 | Transfer Pack Container 600 mL with Coupler. Sterile Fluid Path | KSR | Container, Empty, For Collection & Processing Of Blood & Blood Components | Transfer Pack | |
19 | 10811137010629 | 4R2004 | 4R2004 | Quadruple Transfer Pack Container 150 mL with Coupler. Sterile Fluid Path | KSR | Container, Empty, For Collection & Processing Of Blood & Blood Components | Transfer Pack | |
20 | 10811137010612 | 4R2001 | 4R2001 | Transfer Pack Container 150 mL with Coupler. Sterile Fluid Path | KSR | Container, Empty, For Collection & Processing Of Blood & Blood Components | Transfer Pack | |
21 | 10811137010551 | 4R2024 | 4R2024 | Transfer Pack Container 600 mL with Male Luer Adapter. Sterile Fluid Path | KSR | Container, Empty, For Collection & Processing Of Blood & Blood Components | Transfer Pack | |
22 | 10811137010544 | 4R2014 | 4R2014 | Transfer Pack Container 300 mL with Coupler. Sterile Fluid Path | KSR | Container, Empty, For Collection & Processing Of Blood & Blood Components | Transfer Pack | |
23 | 10811137010490 | 4R2032 | 4R2032 | Transfer Pack Container 1000 mL with Coupler. Sterile Fluid Path | KSR | Container, Empty, For Collection & Processing Of Blood & Blood Components | Transfer Pack | |
24 | 00811137013043 | 5S9803 | 5S9803 | Fenwal DXT Relay is a Microsoft WINDOWS-based software application intended to b Fenwal DXT Relay is a Microsoft WINDOWS-based software application intended to be used by trained blood center professionals to receive and transmit data between blood bank instruments (apheresis and nonapheresis) and Computer Systems. The data may also be stored in and accessed from Fenwal DXT Relay's database. | MMH,OUG | Software, Blood Bank, Stand Alone Products,Medical Device Data System | 1 | Fenwal DXT Relay Release 2.2 |
25 | 00811137010134 | 4R5700 | 4R5700 | For Collection of One Leukoreduced Red Blood Cell Product and Concurrent Plasma For Collection of One Leukoreduced Red Blood Cell Product and Concurrent Plasma Product by Centrifugation. For Use With the ALYX™ System.Sterile Fluid Path. | GKT | Separator, Automated, Blood Cell, Diagnostic | ALYX™ RBC/Plasma Kit |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00811137010714 | 4C2468 | 4C2468 | SEPACELL Pre-Storage Leukocyte Reduction Set for Red Cells. Sterile Fluid Path | NA | FENWAL, INC. |
2 | 00811137010486 | 4C4300 | 4C4300 | LEUKOCONNECT Pre-Storage Sterile Connect Leukoreduction Set with SEPACELL RS-200 LEUKOCONNECT Pre-Storage Sterile Connect Leukoreduction Set with SEPACELL RS-2000 Filter for Red Blood Cells in Additive Solution. Sterile Fluid Path | Leukoconnect | FENWAL, INC. |
3 | 00811137010462 | 4C2300 | 4C2300 | SEPACELL Pre-Storage Leukocyte Reduction Set for Red Cells. Sterile Fluid Path | NA | FENWAL, INC. |
4 | 00811137010431 | 4C4502 | 4C4502 | Sepacell PLD-10ALeukocyte Reduction Y-Administration Set. Sterile Fluid Path | NA | FENWAL, INC. |
5 | 20887691308745 | 430-40 | Leukocyte Reduction Filter System for Red Blood Cells with BPF4 High Efficiency Leukocyte Reduction Filter System for Red Blood Cells with BPF4 High Efficiency Filter, 16-Segment Tubing, Storage Bag and Sample Pouch | Leukocyte SC RC | HAEMONETICS CORPORATION | |
6 | 10887691313940 | BPFAPLUS | High Efficiency Post-Process Filter System for Leukocyte Removal From Red Cells | Haemonetics | HAEMONETICS CORPORATION | |
7 | 10887691305792 | LRF6BLA | LRF6 High Efficiency Leukocyte Reduction Filter for Platelets with Attached 600 LRF6 High Efficiency Leukocyte Reduction Filter for Platelets with Attached 600 mL Transfer Bag | Haemonetics | HAEMONETICS CORPORATION | |
8 | 10887691305303 | LRF10BLA | LRF10 High Efficiency Leukocyte Reduction Filter for Platelets with Attached 1.3 LRF10 High Efficiency Leukocyte Reduction Filter for Platelets with Attached 1.3 L CLX Transfer Bag | Haemonetics | HAEMONETICS CORPORATION | |
9 | 10887691304214 | BPFBLA | Leukotrap High Efficiency Leukocyte Reduction Filtration System for Red Blood Ce Leukotrap High Efficiency Leukocyte Reduction Filtration System for Red Blood Cells with BPF4 Filter | Haemonetics Leukotrap SC RC | HAEMONETICS CORPORATION | |
10 | 10887691003872 | NEO1 | Neonatal High Efficiency Leukocyte Reduction Filter for Red Blood cells with Att Neonatal High Efficiency Leukocyte Reduction Filter for Red Blood cells with Attached 175 mL PVC Aliquot Bag with Needleless Injection Port | Haemonetics | HAEMONETICS CORPORATION | |
11 | 10887691003865 | RCQT | High Efficiency Rapid Flow Leukocyte Reduction Filter Set for Single Unit Blood High Efficiency Rapid Flow Leukocyte Reduction Filter Set for Single Unit Blood Transfusion | Haemonetics | HAEMONETICS CORPORATION | |
12 | 10887691003858 | PL6YS | PL High Efficiency Leukocyte Reduction Filter with Attached Y-Administration Set PL High Efficiency Leukocyte Reduction Filter with Attached Y-Administration Set and Self-leveling Drip Chamber for Platelets | Haemonetics | HAEMONETICS CORPORATION | |
13 | 10887691003841 | PL6KS | PL High Efficiency Leukocyte Reduction Filter with Attached Straight Administrat PL High Efficiency Leukocyte Reduction Filter with Attached Straight Administration Set and Self-leveling Drip Chamber for Platelets | Haemonetics | HAEMONETICS CORPORATION | |
14 | 10887691001243 | SB1E | LipiGuard SB Reinfusion Filter for Salvaged Blood | LipiGuard SB | HAEMONETICS CORPORATION | |
15 | 10887691000758 | BPFB | BPF Leukocyte Reduction Filteration System | Haemonetics | HAEMONETICS CORPORATION | |
16 | 10887691000734 | RS1 | RS Leukocyte Reduction Filter for Intraoperatively Salvaged Washed Blood | Haemonetics | HAEMONETICS CORPORATION | |
17 | 10887691000703 | LRFP | LRF High Efficiency Leukocyte Reduction Filtration System for Platelets | Haemonetics | HAEMONETICS CORPORATION | |
18 | 10887691000680 | SQ40SY | Microaggregate Blood Transfusion Filter with Attached Y-Type Administration Set Microaggregate Blood Transfusion Filter with Attached Y-Type Administration Set with 3 mm Tubing | Haemonetics | HAEMONETICS CORPORATION | |
19 | 10887691000673 | SQ40SK | Microaggregate Blood Transfusion Filter with Attached Straight Administration Se Microaggregate Blood Transfusion Filter with Attached Straight Administration Set with 3 mm Tubing | Haemonetics | HAEMONETICS CORPORATION | |
20 | 10887691000666 | SQ40S | Blood Transfusion Filter | Haemonetics | HAEMONETICS CORPORATION | |
21 | 10887691000598 | RCXL1Y | RCXL1Y High Efficiency Leukocyte Reduction Filter with Attached Y-Type Administr RCXL1Y High Efficiency Leukocyte Reduction Filter with Attached Y-Type Administration Set for Single Unit Blood Transfusion | RCXL1Y High Efficiency Leukocyte Reduction Filter | HAEMONETICS CORPORATION | |
22 | 10887691000581 | RCXL1K | RCXL1 High Efficiency Leukocyte Redution Filter with Attached Straight Administr RCXL1 High Efficiency Leukocyte Redution Filter with Attached Straight Administration Set for Single Unit Blood Transfusion | RCXL1 | HAEMONETICS CORPORATION | |
23 | 10887691000550 | PXL8Y | PXL 8 High Efficiency Leukocyte Reduction Filter for Platelets with Attached Y-T PXL 8 High Efficiency Leukocyte Reduction Filter for Platelets with Attached Y-Type Administration Set | PXL 8 | HAEMONETICS CORPORATION | |
24 | 10887691000543 | PXL8K | High Efficiency Leukocyte Reduction Filter for Platelets with Attached Straight High Efficiency Leukocyte Reduction Filter for Platelets with Attached Straight Administration Set | Haemonetics | HAEMONETICS CORPORATION | |
25 | 10887691000536 | PXL8C | PXL 8 High Efficiency Leukocyte Reduction Filter for Platelets with Attached Extension Set | PXL 8 | HAEMONETICS CORPORATION | |
26 | 10887691000505 | PXL12K | PXL 12 High Efficiency Leukocyte Reduction Filter with Attached Straight Adminis PXL 12 High Efficiency Leukocyte Reduction Filter with Attached Straight Administration Set | PXL 12 High Efficiency Leukocyte Reduction Filter | HAEMONETICS CORPORATION | |
27 | 10887691000499 | PXL12C | PXL 12 High Efficiency Leukocyte Reduction Filter for Platelets with Attached Ex PXL 12 High Efficiency Leukocyte Reduction Filter for Platelets with Attached Extension Tubing | PXL 12 High Efficiency Leukocyte Reduction Filter for Platelets | HAEMONETICS CORPORATION | |
28 | 10887691000437 | LRF10S | LRF 10 High Efficiency Leukocyte Reduction Filter for platelets with Attached 1. LRF 10 High Efficiency Leukocyte Reduction Filter for platelets with Attached 1.3L CLX Transfer Bag | Haemonetics | HAEMONETICS CORPORATION | |
29 | 10887691000420 | LPS2 | LPS High Efficiency Leukocyte Reuction Filter for Plasma | Haemonetics | HAEMONETICS CORPORATION | |
30 | 10887691000192 | PL6T | PL High Efficiency Leukocyte reduction filter for platelets with attached extens PL High Efficiency Leukocyte reduction filter for platelets with attached extension tubing and air vent | PL High Efficiency Leukocyte Reduction Filter | HAEMONETICS CORPORATION | |
31 | 10887691000178 | RCEZKS | FILTER RC EZ PRIME W/S SET | Haemonetics | HAEMONETICS CORPORATION | |
32 | 10887691000161 | RCEZ1T | EZ Prime Self-Priming High Efficiency Leukocyte Reduction Filter Set for Singl EZ Prime Self-Priming High Efficiency Leukocyte Reduction Filter Set for Single Unit Blood Transfusion | Haemonetics EZ Prime | HAEMONETICS CORPORATION | |
33 | 10887691000116 | PL1B | PL High efficiency Leukocyte Reduction Filter for a Single Unit of Platelet Conc PL High efficiency Leukocyte Reduction Filter for a Single Unit of Platelet Concentrate with Attached 175 mL PVC Transfer bag with Needleless Injection Port | Haemonetics | HAEMONETICS CORPORATION | |
34 | 04052682004308 | 4C4300 | 4C4300 | LeukoConnect - Pre-Storage Sterile Connect Leukoreduction Set with Sepacell RS-2 LeukoConnect - Pre-Storage Sterile Connect Leukoreduction Set with Sepacell RS-2000 Filter for Red Blood Cells in Additive Solution | Leukoconnect | FRESENIUS KABI AG |
35 | 03567051503128 | MRV | MRV6000LD | 500 mL Phlebotomy Bag with Needle. | MRV6000LD - Therapeutic Phlebotomy Bag w/Needle | MACO PRODUCTIONS |
36 | 03567051503111 | VSE | VSE4002XD | 600 mL Empty Bag. | VSE4002XD - Empty Bag 600 mL | MACO PRODUCTIONS |
37 | 03567050070324 | VSL | VSL7000YD | 600 mL Phlebotomy Bag with Luer Lock. | VSL7000YD - Therapeutic Phlebotomy Bag | MACO PRODUCTIONS |
38 | 03567050070317 | VSL | VSL7001PD | 600 mL Phlebotomy Bag with Needle. | VSL7001PD - Therapeutic Phlebotomy Bag w/Needle | MACO PRODUCTIONS |
39 | 03567050069908 | VQE | VQE2001XD | 300ml Quad Splitting Empty Bags. | VQE2001XD - 4 Empty Bags 300 mL | MACO PRODUCTIONS |
40 | 03567050069687 | VSE | VSE8004XD | 600 mL Empty Bag for Pooling of Blood Components. | VSE8004XD - Empty Bag 600 mL 6-Way Man | MACO PRODUCTIONS |
41 | 03567050052740 | VSE | VSE3010XD | 300 mL Empty Bag for Pooling of Blood Components. | VSE3010XD - Empty Bag 300 mL 6-Way Man | MACO PRODUCTIONS |
42 | 03567050035347 | KSV | KSV0004XD | Leucolab LCG2b Leukoreduction System for Red Blood Cells. The Leucolab LCG2b pr Leucolab LCG2b Leukoreduction System for Red Blood Cells. The Leucolab LCG2b product consists of a transfer line, drip chamber, leukoreduction filter, by-pass tubing and transfer bag. It is sterilized by electron beam (beta irradiation) and is supplied with sterile and non-pyrogenic fluid pathways. | LCG2b with AS-1, AS-3 and AS-5 | MACO PRODUCTIONS |
43 | 00817827024054 | N40-960-37 | N40-960-37 | Neonatal/Pediatric Syringe Set 40µ Filter with 60cc Syringe | N/A | CHARTER MEDICAL, LTD. |
44 | 00817827024047 | N40-960-35 | N40-960-35 | Neonatal/Pediatric Syringe Set 40µ Filter with 35cc Monoject® Syringe | N/A | CHARTER MEDICAL, LTD. |
45 | 00817827024030 | N40-960-33 | N40-960-33 | Neonatal/Pediatric Syringe Set 40µ Filter with Syringe Adapter | N/A | CHARTER MEDICAL, LTD. |
46 | 00817827024023 | N40-960-10 | N40-960-10 | Neonatal/Pediatric Syringe Set 40µ Filter with 50cc Syringe | N/A | CHARTER MEDICAL, LTD. |
47 | 00817827024016 | N40-960-00 | N40-960-00 | Neonatal/Pediatric Syringe Set 40µ Filter with 30cc Sryinge | N/A | CHARTER MEDICAL, LTD. |