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 | 00811137012695 | 4C2498H | 4C2498H | Y-Type Connector Set with Luer Lock | KSB | Set, Transfer (Blood/Plasma) | 2 | NA |
10 | 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 |
11 | 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 | |
12 | 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 |
13 | 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 | |
14 | 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 | CAK | Microfilter, Blood Transfusion | Leukoconnect | |
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 | 10866305000278 | TCD B40 | 480-B40-00-2038 | The TCDB40 Wafer Assembly consists of a copper wafer and plastic holder. The pla The TCDB40 Wafer Assembly consists of a copper wafer and plastic holder. The plastic holder is color coded to assist the operator with proper placement/insertion. The wafer assembly is placed in the TCDB40 Sterile Tube Welding device prior to the weld process. The copper wafer is separated from the plastic holder during the welding process and after welding is completed both the plastic holder and the copper wafer are removed from the device and discarded. The wafers are single use only and cannot be reused. The TCDB40 Sterile Tube Welding device will not operate without a wafer assembly inserted and will not operate with a used a wafer. The TCDB40 wafer assemblies are packaged in 8 plastic trays. Each tray has 25 individual wafer assemblies. Each box referred to as a case has a total of 200 individual TCDB40 wafer assemblies. | TCD B40 Wafers | GENESIS BPS LLC |
2 | 10866305000254 | GRW-430 | 480-RW-2478-03 | The Blade Module consists of a stainless steel blade that cuts the PVC tube segm The Blade Module consists of a stainless steel blade that cuts the PVC tube segments. The Blade Module is designed with a built in service meter to record the number of welds performed on the device. This feature monitors the usage endured by the Blade Module. The operator is notified when the Blade Module requires replacement. If the operator fails to respond to the warning message and replace the Blade Module the Genesis Rapid Weld STW will not operate once the Blade Module weld cycle limit is reached. Operation will resume once a replacement Blade Module is installed. | RapidWeld Blade Module Kit | GENESIS BPS LLC |
3 | 10866305000247 | GRW-430 | 480-RW-2478-02 | The Blade Module consists of a stainless steel blade that cuts the PVC tube segm The Blade Module consists of a stainless steel blade that cuts the PVC tube segments. The Blade Module is designed with a built in service meter to record the number of welds performed on the device. This feature monitors the usage endured by the Blade Module. The operator is notified when the Blade Module requires replacement. If the operator fails to respond to the warning message and replace the Blade Module the Genesis Rapid Weld STW will not operate once the Blade Module weld cycle limit is reached. Operation will resume once a replacement Blade Module is installed. | RapidWeld Blade Module Kit | GENESIS BPS LLC |
4 | 10866305000230 | GRW-430 | 480-RW-2478-01 | The Blade Module consists of a stainless steel blade that cuts the PVC tube segm The Blade Module consists of a stainless steel blade that cuts the PVC tube segments. The Blade Module is designed with a built in service meter to record the number of welds performed on the device. This feature monitors the usage endured by the Blade Module. The operator is notified when the Blade Module requires replacement. If the operator fails to respond to the warning message and replace the Blade Module the Genesis RapidWeld STW, Model GRW-430 will not operate once the Blade Module weld cycle limit is reached. Operation will resume once a replacement Blade Module is installed. | RapidWeld Blade Module Kit | GENESIS BPS LLC |
5 | 10866305000223 | TCD B40 | 480-B40-00-1274 | The TCD B40 Wafer Assembly consists of a copper wafer and a plastic holder. The The TCD B40 Wafer Assembly consists of a copper wafer and a plastic holder. The plastic holder is color coded to assist the operator with proper placement/insertion.The wafer assembly is placed in the device prior to the weld process. During the welding process the copper wafer is separated from the plastic holder, and after welding is completed, both the holder and wafer are removed from the device and discarded. The wafers are one-time use only and cannot be reused. The TCD B40 device will not operate without a wafer assembly inserted and will not operate with a used wafer. The TCD B40 wafer assemblies are packaged in boxes containing 240 wafer assemblies in each box referred to as a case. | TCD B40 Wafers | GENESIS BPS LLC |
6 | 10811137010704 | 4C2243 | 4C2243 | Plasma Transfer Sets with Two Spikes. Sterile Fluid Path | NA | FENWAL, INC. |
7 | 10811137010650 | 4C2240 | 4C2240 | Plasma Transfer Sets with Spike and Male Luer Adapter. Sterile Fluid Path | NA | FENWAL, INC. |
8 | 05020583620032 | 62003 | Weld Integrity Test Kit for TSCD®II Sterile Tubing Welder | TSCD®-II | TERUMO BCT, INC. | |
9 | 05020583620025 | 62002 | SCD®-IIB Sterile Tubing Welder | SCD®-IIB | TERUMO BCT, INC. | |
10 | 05020583620018 | 62001 | Sterile Tubing Welder | TSCD® II | TERUMO BCT, INC. | |
11 | 05020583620001 | 62000 | Terumo Sterile Tubing Welder | TSCD®-II | TERUMO BCT, INC. | |
12 | 05020583300088 | METCM2 | Trucise 2.0 Communication Module | Trucise® 2.0 Total System | TERUMO BCT, INC. | |
13 | 05020583300064 | 3NCC947 | 3-Ncc947 Weld Integrity Test Kit | TSCD®-II | TERUMO BCT, INC. | |
14 | 05020583300040 | 3NCC945 | Weld Integrity Test Kit | TSCD® | TERUMO BCT, INC. | |
15 | 05020583300033 | 3MESC203A | Sterile Tubing Welder | TSCD® II | TERUMO BCT, INC. | |
16 | 05020583300026 | 3NCC986 | SCD II Final Assembly | SCD® IIB | TERUMO BCT, INC. | |
17 | 04987350726971 | SC*W017 | TSCD Wafers | TSCD | TERUMO CORPORATION | |
18 | 04086000860215 | 9028721 | 9028721 | The CompoDock is used for the production of special cellular blood components, e The CompoDock is used for the production of special cellular blood components, e.g. in blood banks where tube connections are needed that provide protection against microbial contamination.The CompoDock is a high-frequency connection device that permits sterile connection of medical PVC tubes to one another.Here, sterile connection is achieved when germs from the environment are prevented from being carried into the closed systems. The closed system is maintained after the docking process. | CompoDock | FRESENIUS KABI AG |
19 | 04046964188572 | V2203 | V2203 | PLAS TRANS/RCL/SPK NDL ADPT/27 | Blood Administration Set | B. BRAUN MEDICAL INC. |
20 | 00887868260285 | PN-7212 | PN-7212 | Rejuvesol™ | CITRA LABS, LLC | |
21 | 00866305000264 | GRW-430-02 | 480-RW-2607-02 | The Genesis RapidWeld II STW, model GRW-430-02, is a medical device used in labo The Genesis RapidWeld II STW, model GRW-430-02, is a medical device used in laboratories, designed for the purpose of making sterile connections in PVC tubing in blood processing applications. The device enables fluid transfer while maintaining a closed system without the need for a consumable (disposable wafer). | Genesis RapidWeld II STW Sterile Tube Welder | GENESIS BPS LLC |
22 | 00866305000219 | TCD B40 | 480-B40-00-1245 | The TCD B40 is a bench top, portable device intended for use by appropriately tr The TCD B40 is a bench top, portable device intended for use by appropriately trained and qualified personnel in hospital/laboratory/clinical settings for the purpose of making sterile connections of 3.9 mm to 4.5 mm PVC tubing in blood processing applications. | Total Containment Device (TCD) | GENESIS BPS LLC |
23 | 00866305000202 | GRW-430 | 480-RW-2607-00 | The Genesis Rapid Weld STW is a medical device used in laboratories, designed fo The Genesis Rapid Weld STW is a medical device used in laboratories, designed for the purpose of making sterile connections in PVC tubing in blood processing applications. The device enables fluid transfer while maintaining a closed system without the need for a consumable (disposable wafer). | Genesis RapidWeld STW Sterile Tube Welder | GENESIS BPS LLC |
24 | 00817827026218 | CT-018-94 | CT-018-94 | Fluid Transfer Sets 6" PVC with Spike and Male Luer | Advect | CHARTER MEDICAL, LTD. |
25 | 00817827026201 | CT-018-90 | CT-018-90 | Fluid Transfer Sets 6" PVC with Spike Adapter and Luer | Advect | CHARTER MEDICAL, LTD. |
26 | 00817827026195 | CT-018-50 | CT-018-50 | Fluid Transfer Sets 6" PVC - Spike with Female Luer and Twist off | Advect | CHARTER MEDICAL, LTD. |
27 | 00817827026188 | CT-018-10 | CT-018-10 | Fluid Transfer Sets 10 Lead Harness with Port Adapter (6" L) | Advect | CHARTER MEDICAL, LTD. |
28 | 00817827026171 | CT-018-08 | CT-018-08 | Fluid Transfer Sets 8 Lead Harness with Port Adapter (6" L) | Advect | CHARTER MEDICAL, LTD. |
29 | 00817827026164 | CT-014-XL | CT-014-XL | Fluid Transfer Sets 5mL Syringe with PVC Lead and Spike Adapter | Advect™ | CHARTER MEDICAL, LTD. |
30 | 00817827026157 | CT-014-VAS | CT-014-VAS | Fluid Transfer Sets 6" PVC Lead with Syringe and Vial Adapters | Advect™ | CHARTER MEDICAL, LTD. |
31 | 00817827026140 | CT-014-UPS | CT-014-UPS | Fluid Transfer Sets 12 PVC Leads with Adapters | Advect™ | CHARTER MEDICAL, LTD. |
32 | 00817827026133 | CT-014-SSV | CT-014-SSV | Fluid Transfer Sets 12mL Syringe with 3 PVC Leads and Adapters | Advect™ | CHARTER MEDICAL, LTD. |
33 | 00817827026126 | CT-014-SSS | CT-014-SSS | Fluid Transfer Sets 50mL Syringe with 6" PVC Lead | Advect™ | CHARTER MEDICAL, LTD. |
34 | 00817827026119 | CT-014-SPS | CT-014-SPS | Fluid Transfer Sets 3 PVC Leads with Spike, Port, Syringe Adapters | Advect™ | CHARTER MEDICAL, LTD. |
35 | 00817827026102 | CT-014-RPS | CT-014-RPS | Fluid Transfer Sets 3 PVC Leads with Sampling Valve and Spike | Advect™ | CHARTER MEDICAL, LTD. |
36 | 00817827026096 | CT-014-CVT | CT-014-CVT | Fluid Transfer Sets 10" C-Flex to PVC Lead | Advect™ | CHARTER MEDICAL, LTD. |
37 | 00817827026089 | CT-014-94 | CT-014-94 | Fluid Transfer Sets 2.25" PVC with Spike and Male Luer | Advect™ | CHARTER MEDICAL, LTD. |
38 | 00817827026072 | CT-014-92 | CT-014-92 | Fluid Transfer Sets 2.25" PVC with Spike and Female Luer | Advect™ | CHARTER MEDICAL, LTD. |
39 | 00817827026065 | CT-014-90 | CT-014-90 | Fluid Transfer Sets 4" PVC with Spike Adapter and Luer | Advect™ | CHARTER MEDICAL, LTD. |
40 | 00817827026058 | CT-014-50 | CT-014-50 | Fluid Transfer Sets Spike with Female Luer and Twist off | Advect™ | CHARTER MEDICAL, LTD. |
41 | 00817827026041 | CT-014-10 | CT-014-10 | Fluid Transfer Sets 10 Lead Harness with Port Adapter | Advect™ | CHARTER MEDICAL, LTD. |
42 | 00817827026034 | CT-014-08 | CT-014-08 | Fluid Transfer Sets 8 Lead Harness with Port Adapter | Advect™ | CHARTER MEDICAL, LTD. |
43 | 00817827026027 | CT-014-06 | CT-014-06 | Fluid Transfer Sets 6 Lead Harness with Port Adapter | Advect™ | CHARTER MEDICAL, LTD. |
44 | 00817827026010 | CT-014-00 | CT-014-00 | Fluid Transfer Sets 24" PVC with 2 Spike Adapters | Advect™ | CHARTER MEDICAL, LTD. |
45 | 00817827021152 | 03-220-XL | 03-220-XL | Plasma Transfer Set 5mL Syringe with Tubing Assembly | N/A | CHARTER MEDICAL, LTD. |
46 | 00817827021145 | 03-220-TMBC | 03-220-TMBC | Plasma/Fluid Transfer Set 100 mL Bag, 12 mL Syringe and Adapter Cap Assembly | N/A | CHARTER MEDICAL, LTD. |
47 | 00817827021138 | 03-220-TM | 03-220-TM | Plasma/Fluid Transfer Set 12" tubing with needle assembly and 100mL bag | N/A | CHARTER MEDICAL, LTD. |
48 | 00817827021121 | 03-220-BD | 03-220-BD | Plasma/Fluid Transfer Set with Tube Adapter | N/A | CHARTER MEDICAL, LTD. |
49 | 00817827021114 | 03-220-BC | 03-220-BC | Plasma/Fluid Transfer Set 10ml Syringe and Adapter Cap Assembly | N/A | CHARTER MEDICAL, LTD. |
50 | 00817827021107 | 03-220-BC-20 | 03-220-BC-20 | Plasma/Fluid Transfer Set 20ml Syringe and Adapter Cap | N/A | CHARTER MEDICAL, LTD. |