No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00886368000773 | 80068 | X-WASH Control Module | LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | 1 | X-WASH | |
2 | 00886368000650 | 80066 | PXP Docking Station | OAO | Cord Blood Processing System And Storage Container | 2 | PXP | |
3 | 00886368000636 | 80065 | PXP Control Module | OAO | Cord Blood Processing System And Storage Container | 2 | PXP | |
4 | 00886368000711 | 80063 | PXP Disposable Cartridge | OAO | Cord Blood Processing System And Storage Container | 2 | PXP | |
5 | 00886368001015 | 80088 | PXP Disposable Cartridge | OAO | Cord Blood Processing System And Storage Container | 2 | PXP | |
6 | 00886368000971 | 80088 | PXP Disposable Cartridge | OAO | Cord Blood Processing System And Storage Container | 2 | PXP | |
7 | 00886368000964 | 80087 | PXP Disposable Cartridge | OAO | Cord Blood Processing System And Storage Container | 2 | PXP | |
8 | 00886368000520 | 8-5104 | 8-5104 | AXP Accessory | OAO | Cord Blood Processing System And Storage Container | 2 | Counterweight, AXP |
9 | 00886368000445 | 8-5114 | 8-5114 | OAO | Cord Blood Processing System And Storage Container | 2 | AXP Adapter Set, Sorvall 11754/11297 | |
10 | 00886368000346 | 8-5102 | 8-5102 | Cord blood processing system | OAO | Cord Blood Processing System And Storage Container | AXP Device | |
11 | 00886368000322 | 70176 | 8-5110 | Utilized for quality control testing of the AXP Device. | OAO | Cord Blood Processing System And Storage Container | 2 | QC Bagset |
12 | 00886368000315 | 8-5137 | Cell separation processing and collection bag set. | JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | 1 | MXP Processing Bagset | |
13 | 00886368000308 | 8-5101 | Cord blood processing system and storage container | OAO | Cord Blood Processing System And Storage Container | 2 | AXP Disposable Processing Bagset | |
14 | 00886368000032 | 80096 | X-Wash Accessory Kit | LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | 1 | X-Wash Accessory Kit | |
15 | B039SGI00910 | SGI-0091 | CryoPRO™-2 Cryopreservation/Storage Bag Set | OAO | Cord Blood Processing System And Storage Container | CryoPRO™-2 | ||
16 | 00886368000421 | 8-5113 | 8-5113 | OAO | Cord Blood Processing System And Storage Container | 2 | AXP Adapter, 101-102mm Round Bucket | |
17 | 00886368000414 | 8-5112 | 8-5112 | OAO | Cord Blood Processing System And Storage Container | 2 | AXP Large Oval Bucket Adapter Set | |
18 | 00886368000070 | 80103 | PXP-1000 Docking Station | OAO | Cord Blood Processing System And Storage Container | PXP-1000 Docking Station | ||
19 | B039SGI04420 | SGI-0442 | CryoPRO™-5 Cryopreservation/Storage Bag Set | OAO | Cord Blood Processing System And Storage Container | CryoPRO™-5 | ||
20 | 00886368000933 | 80084 | X-LAB Disposable Cartridge | LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | 1 | X-LAB | |
21 | 00886368000926 | 80083 | X-LAB Disposable Cartridge | LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | 1 | X-LAB | |
22 | 00886368000759 | 80069 | X-LAB Docking Station | LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | 1 | X-LAB | |
23 | 00886368000735 | 80067 | X-LAB Control Module | LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | 1 | X-LAB | |
24 | 00886368000681 | 80060 | X-LAB Disposable Cartridge | LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | 1 | X-LAB | |
25 | 00886368001022 | 80084 | X-LAB Disposable Cartridge | LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | 1 | X-LAB | |
26 | 00886368000988 | 80089 | X-LAB Kit | LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | 1 | X-LAB | |
27 | 00886368000506 | 8-4100-0 | 8-4100-0 | Accessory to the BioArchive System | KSE | Refrigerator, Freezer, Blood Storage | Auto Volume Expressor | |
28 | 00886368000384 | 8-5138 | 8-5138 | Cell separation processing, docking station | JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | 1 | MXP Docking Station |
29 | B039SGI07770 | SGI-0777 | The SynGen™ DataTrak software is the application code that provides the interfac The SynGen™ DataTrak software is the application code that provides the interface between the operator and the SynGenX™-1000 System through a host PC computer. It downloads processing and system information from the CM and stores it in a database on the host PC computer. The data collected includes information gathered during each buffy coat harvest run including output of the accelerometer, infrared sensor readings, and timing and duration of the pinch and release of the cell transfer tubes. This collected data serves to document each processing run of the cord blood to support cGMP compliance. | OAO | Cord Blood Processing System And Storage Container | 2 | SynGen® DataTrak | |
30 | 00886368000940 | 80085 | X-WASH Disposable Cartridge | LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | 1 | X-WASH | |
31 | 00886368000797 | 80070 | X- WASH DOCKING STATION | LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | X- WASH | ||
32 | 00886368000704 | 80061 | X-WASH Disposable Cartridge | LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | 1 | X-WASH | |
33 | 00886368001039 | 80086 | X-WASH Disposable Cartridge Copy | LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | 1 | X-WASH | |
34 | 00886368000995 | 80090 | X-WASH Kit | LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | 1 | X-WASH | |
35 | 00886368000513 | 7-00-288 | 7-00-288 | AXP Accessory | OAO | Cord Blood Processing System And Storage Container | 2 | Xpresstrak Software Kit |
36 | 00886368000490 | 8-6200-0 | 8-6200-0 | Accessory to the BioArchive System | KSE | Refrigerator, Freezer, Blood Storage | Impulse Overwrap Bag Sealer 110v | |
37 | 00886368000223 | 80122 | PXP-LAVARE Docking Station, packaged | OAO | Cord Blood Processing System And Storage Container | PXP-LAVARE | ||
38 | 00886368000216 | 80121 | PXP-LAVARE Control Module, packaged | OAO | Cord Blood Processing System And Storage Container | PXP-LAVARE | ||
39 | 00886368000209 | 80120 | PXP-LAVARE Disposable Cartridge | OAO | Cord Blood Processing System And Storage Container | PXP-LAVARE | ||
40 | 00886368000193 | 80118 | PXP-LAVARE Disposable Cartridge | OAO | Cord Blood Processing System And Storage Container | PXP-LAVARE | ||
41 | 00886368000186 | 80118 | PXP-LAVARE Disposable Cartridge | OAO | Cord Blood Processing System And Storage Container | PXP-LAVARE | ||
42 | 00886368000919 | 80080 | X-Counterweight High Packaged | LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | 1 | X-Counterweight | |
43 | 00886368000896 | 80079 | X-Counterweight Medium Packaged | LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | 1 | X-Counterweight | |
44 | 00886368000872 | 80073 | X-Counterweight Low Packaged | LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | 1 | X-Counterweight | |
45 | 00886368000858 | 80074 | X-Balance Ring Kit | LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | 1 | X-Balance Ring Kit | |
46 | 00886368001008 | 80091 | X-Counterweight Kit | LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | X-Counterweight | ||
47 | 00886368000391 | 8-5142 | 8-5142 | Startup kit for the MXP System | JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | 1 | MXP Start Up Kit |
48 | 00886368000360 | 8-5103 | 8-5103 | Cord blood processing system docking station | OAO | Cord Blood Processing System And Storage Container | AXP Docking Station | |
49 | 00886368000841 | 150040 | DataTrak Software | LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | 1 | DataTrak | |
50 | 00886368000568 | 8-5144 | 8-5144 | OAO | Cord Blood Processing System And Storage Container | 2 | AutoXpress Platform Counterbalance CG |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 08435389816997 | PRGF S.V | ENDORET SYSTEM V CENTRIFUGE | BIOTECHNOLOGY INSTITUTE SL | ||
2 | 07640125650594 | Sepax RM | 14100 | Sepax RM | BIOSAFE S.A. | |
3 | 07640125650457 | Separation Chamber Holder | 6033 | Separation Chamber Holder | BIOSAFE S.A. | |
4 | 07640125650341 | FA-200.1 | 10043 | Sepax Kit Accessory | Double Spike Accessory | BIOSAFE S.A. |
5 | 07640125650303 | CS-900.2 | 10008 | Regenerative medicine-Single-use kits | BIOSAFE S.A. | |
6 | 07640125650280 | CS-600.1 | 10006 | Regenerative medicine-Single-use kits | BIOSAFE S.A. | |
7 | 07640125650112 | CS-490.1 | 10001 | Sepax single-use kit | BIOSAFE S.A. | |
8 | 07640125650099 | CS-470.1 | 10005 | Sepax single-use kit | BIOSAFE S.A. | |
9 | 07640125650075 | CS-470.0 | 10034 | Regenerative medicine-Single-use kits | BIOSAFE S.A. | |
10 | 05034480000446 | ORO1H | ORO1H | Bi-directional oxygenator gas line filter for use in gas lines and is indicated Bi-directional oxygenator gas line filter for use in gas lines and is indicated for the removal of bacteria, scale and other contaminants from oxygen and other medical gases. | Pall® Oxygenator Gas Line Filter | PALL INTERNATIONAL SÀRL |
11 | 05020583514997 | 51499 | SmartPrep® 3 Multi-Cellular Processing System, Red Cell Reduction Hardware Kit | HARVEST® | TERUMO BCT, INC. | |
12 | 05020583514980 | 51498 | SmartPrep® 3 Multi-Cellular Processing System, 4 Place Process Disposable Holder | HARVEST® SmartPrep® | TERUMO BCT, INC. | |
13 | 05020583514966 | 51496 | Accessory Kit | HARVEST® Adiprep® | TERUMO BCT, INC. | |
14 | 05020583514959 | 51495 | SmartPrep® 3 Multi-Cellular Processing System, Four Place Rotor | HARVEST® SmartPrep® | TERUMO BCT, INC. | |
15 | 05020583514942 | 51494 | SmartPrep® 2 Centrifuge System, Two Place Rotor | HARVEST® SmartPrep® | TERUMO BCT, INC. | |
16 | 05020583514935 | 51493 | SmartPrep® 3 Multi-Cellular Processing System, Balance Weight/ tube Adapter TA-60 | HARVEST® | TERUMO BCT, INC. | |
17 | 05020583514928 | 51492 | TA-30 Balance Weight / Tube Adapter PRP30 BMAC® | HARVEST® | TERUMO BCT, INC. | |
18 | 05020583514911 | 51491 | SmartPrep® 3 Multi-Cellular Processing System, TA 20 | HARVEST® SmartPrep® | TERUMO BCT, INC. | |
19 | 05020583514904 | 51490 | SmartPrep® 3 Multi-Cellular Processing System, Balance Weight BW-60 | HARVEST® SmartPrep® | TERUMO BCT, INC. | |
20 | 05020583514898 | 51489 | SmartPrep® 3 Multi-Cellular Processing System, Balance Weight BW-30 | HARVEST® | TERUMO BCT, INC. | |
21 | 05020583514881 | 51488 | SmartPrep® 3 Multi-Cellular Processing System, Balance Weight PRP 20 BMAC® BW-20 | HARVEST® SmartPrep® | TERUMO BCT, INC. | |
22 | 05020583514874 | 51487 | SmartPrep® 3 Multi-Cellular Processing System, Rolling Cart 2 | HARVEST® SmartPrep® | TERUMO BCT, INC. | |
23 | 05020583514867 | 51486 | SmartPrep® 3 Multi-Cellular Processing System, WS-2 Work Station 2 Cart | HARVEST® SmartPrep® | TERUMO BCT, INC. | |
24 | 05020583514836 | 51483 | SmartPrep® 2 Centrifuge System | HARVEST® | TERUMO BCT, INC. | |
25 | 05020583514829 | 51482 | SmartPrep® 2 Centrifuge System | HARVEST® SmartPrep® | TERUMO BCT, INC. | |
26 | 05020583514805 | 51480 | SmartPrep® 3 Multi-Cellular Processing System | HARVEST® | TERUMO BCT, INC. | |
27 | 05020583514782 | 51478 | SmartPrep® 2 Centrifuge System, Two place rotor | HARVEST® SmartPrep® | TERUMO BCT, INC. | |
28 | 05020583514751 | 51475 | SmartPrep® 3 Multi-Cellular Processing System | HARVEST® SmartPrep® | TERUMO BCT, INC. | |
29 | 05020583514744 | 51474 | SmartPRep® 2 Centrifuge System | HARVEST® | TERUMO BCT, INC. | |
30 | 05020583514720 | 51472 | SmartPrep® 3 Multi-Cellular Processing System | HARVEST® | TERUMO BCT, INC. | |
31 | 05020583514706 | 51470 | SmartPRep® 2 Centrifuge System, Two Place Rotor | HARVEST® SmartPrep® | TERUMO BCT, INC. | |
32 | 05020583514300 | 51430 | Bone Marrow Aspirate Concentrate (BMAC) Procedure Pack, BMAC2-240n Bone Marrow P Bone Marrow Aspirate Concentrate (BMAC) Procedure Pack, BMAC2-240n Bone Marrow Procedure Pack | HARVEST® BMAC® | TERUMO BCT, INC. | |
33 | 05020583514294 | 51429 | Bone Marrow Aspirate Concentrate (BMAC2) Procedure Pack, BMAC2-120n Bone Marrow Bone Marrow Aspirate Concentrate (BMAC2) Procedure Pack, BMAC2-120n Bone Marrow Procedure Pack | HARVEST® BMAC® | TERUMO BCT, INC. | |
34 | 05020583514287 | 51428 | Bone Marrow Aspirate Concentrate (BMAC®2) Procedure Pack, BMAC2-30n Bone Marrow Bone Marrow Aspirate Concentrate (BMAC®2) Procedure Pack, BMAC2-30n Bone Marrow Procedure Pack | HARVEST® BMAC® 2 | TERUMO BCT, INC. | |
35 | 05020583514270 | 51427 | Bone Marrow Aspirate Concentrate (BMAC2) Procedure Pack, BMAC2-60n Bone Marrow P Bone Marrow Aspirate Concentrate (BMAC2) Procedure Pack, BMAC2-60n Bone Marrow Procedure Pack | HARVEST® BMAC® | TERUMO BCT, INC. | |
36 | 05020583514256 | 51425 | Bone Marrow Aspirate Concentrate (BMAC2) Procedure Pack, BMAC2-240-01 Bone Marro Bone Marrow Aspirate Concentrate (BMAC2) Procedure Pack, BMAC2-240-01 Bone Marrow Procedure Pack | HARVEST® BMAC® | TERUMO BCT, INC. | |
37 | 05020583514249 | 51424 | Bone Marrow Aspirate Concentrate (BMAC2) Procedure Pack, BMAC2-180-01 Procedure Pack | HARVEST® BMAC® | TERUMO BCT, INC. | |
38 | 05020583514232 | 51423 | Bone Marrow Aspirate Concentrate (BMAC2) Procedure Pack, BMAC2-120-01 Procedure Pack | HARVEST® BMAC® | TERUMO BCT, INC. | |
39 | 05020583514225 | 51422 | Bone Marrow Aspirate Concentrate (BMAC2) Procedure Pack, BMAC2-60-01 Procedure Pack | HARVEST® BMAC® 2 | TERUMO BCT, INC. | |
40 | 05020583514218 | 51421 | Bone Marrow Aspirate Concentrate (BMAC2) Procedure Pack, BMAC2-30-02 Procedure Pack | HARVEST® BMAC® | TERUMO BCT, INC. | |
41 | 05020583514201 | 51420 | Bone Marrow Aspirate Concentrate (BMAC2) Procedure Pack, BMAC2-30-01 Procedure Pack | HARVEST® BMAC® 2 | TERUMO BCT, INC. | |
42 | 05020583514188 | 51418 | Bone Marrow Aspirate Concentrate (BMAC) Procedure Pack, BMAC-120-07 Procedure Pack | HARVEST® BMAC® | TERUMO BCT, INC. | |
43 | 05020583514171 | 51417 | Bone Marrow Aspirate Concentrate (BMAC) Procedure Pack, BMAC-60-07 Procedure Pack | HARVEST® BMAC® | TERUMO BCT, INC. | |
44 | 05020583514164 | 51416 | Bone Marrow Aspirate Concentrate (BMAC) Procedure PackBMAC-30-07 Procedure Pack | HARVEST® BMAC® | TERUMO BCT, INC. | |
45 | 04050674093149 | 4782-4 | 4782-4 | Centrifuge Bucket / Tube Holder (set of 4 matched units)A device intended to com Centrifuge Bucket / Tube Holder (set of 4 matched units)A device intended to compensate for and enable the use of different size test tubes and bottles in a centrifuge rotor bucket or centrifuge tube holder. This is a reusable device. | Bucket | ANDREAS HETTICH GMBH & CO. KG |
46 | 04050674093101 | 4623-R/2 | 4623-R/2 | Centrifuge Bucket / Tube Holder (set of 2 matched units)A device intended to com Centrifuge Bucket / Tube Holder (set of 2 matched units)A device intended to compensate for and enable the use of different size test tubes and bottles in a centrifuge rotor bucket or centrifuge tube holder. This is a reusable device. | Bucket | ANDREAS HETTICH GMBH & CO. KG |
47 | 04050674092975 | 5052-6 | 5052-6 | Centrifuge Bucket / Tube Holder (set of 6 matched units)A device intended to com Centrifuge Bucket / Tube Holder (set of 6 matched units)A device intended to compensate for and enable the use of different size test tubes and bottles in a centrifuge rotor bucket or centrifuge tube holder. This is a reusable device. | Bucket | ANDREAS HETTICH GMBH & CO. KG |
48 | 04050674092661 | 1753-2 | 1753-2 | Centrifuge Bucket / Tube Holder (set of 2 matched units)A device intended to com Centrifuge Bucket / Tube Holder (set of 2 matched units)A device intended to compensate for and enable the use of different size test tubes and bottles in a centrifuge rotor bucket or centrifuge tube holder. This is a reusable device. | Bucket | ANDREAS HETTICH GMBH & CO. KG |
49 | 04050674092654 | 1752-4 | 1752-4 | Centrifuge Bucket / Tube Holder (set of 4 matched units)A device intended to com Centrifuge Bucket / Tube Holder (set of 4 matched units)A device intended to compensate for and enable the use of different size test tubes and bottles in a centrifuge rotor bucket or centrifuge tube holder. This is a reusable device. | Bucket | ANDREAS HETTICH GMBH & CO. KG |
50 | 04050674092609 | 4785-4 | 4785-4 | Centrifuge Bucket / Tube Holder (set of 4 matched units)A device intended to com Centrifuge Bucket / Tube Holder (set of 4 matched units)A device intended to compensate for and enable the use of different size test tubes and bottles in a centrifuge rotor bucket or centrifuge tube holder. This is a reusable device. | Bucket | ANDREAS HETTICH GMBH & CO. KG |