No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 07640125650501 | Traceability Labels for Bioarchive | 7031 | OAO | Cord Blood Processing System And Storage Container | 2 | Traceability Labels for Bioarchive | |
2 | 07640125650518 | Overwrap Bag | 4085 | OAO | Cord Blood Processing System And Storage Container | Overwrap Bag | ||
3 | 07640125650495 | Traceability Labels for cryopreservation | 7011 | OAO | Cord Blood Processing System And Storage Container | 2 | Traceability Labels for cryopreservation | |
4 | 07640125650464 | DMSO Vial Adaptator 7 ml | 6076 | OAO | Cord Blood Processing System And Storage Container | 2 | DMSO Vial Adaptator 7 ml | |
5 | 07640125650433 | Sample Calibrator 0.8 ml | 6074 | OAO | Cord Blood Processing System And Storage Container | 2 | Sample Calibrator | |
6 | 07640125650426 | Sample Calibrator 0.3 ml | 6075 | OAO | Cord Blood Processing System And Storage Container | 2 | Sample Calibrator | |
7 | 07640125650327 | FA-100.1 | 10022 | Sepax Kit Accessories | OAO | Cord Blood Processing System And Storage Container | 2 | DMSO Extension Line |
8 | 07640125650303 | CS-900.2 | 10008 | JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | 1 | Regenerative medicine-Single-use kits | |
9 | 07640125650280 | CS-600.1 | 10006 | JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | 1 | Regenerative medicine-Single-use kits | |
10 | 07640125650075 | CS-470.0 | 10034 | JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | 1 | Regenerative medicine-Single-use kits | |
11 | 07640125650570 | CryoSC-Db Seal positioner | 7035 | OAO | Cord Blood Processing System And Storage Container | 2 | CryoSC-Db Seal positioner | |
12 | 07640125650532 | Metal Storage Canister | 7012 | OAO | Cord Blood Processing System And Storage Container | Metal Storage Canister | ||
13 | 07640125650488 | Press Modular | 7040 | OAO | Cord Blood Processing System And Storage Container | 2 | Press Modular | |
14 | 07640125650365 | FB-100.1 | 10023 | OOF | Cryogenic Cord Blood Storage Container | 2 | CryoSC-S Freezing Bag | |
15 | 07640125650594 | Sepax RM | 14100 | JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | 1 | Sepax RM | |
16 | 07640125650556 | Insertion Tool | 7030 | OAO | Cord Blood Processing System And Storage Container | Insertion Tool | ||
17 | 07640125650471 | DMSO Vial Adaptator 8 ml | 6089 | OAO | Cord Blood Processing System And Storage Container | 2 | DMSO Vial Adaptator 8 ml | |
18 | 07640125650457 | Separation Chamber Holder | 6033 | JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | 1 | Separation Chamber Holder | |
19 | 07640125650440 | Kit Connector | 7033 | OAO | Cord Blood Processing System And Storage Container | 2 | Kit Connector | |
20 | 07640125650587 | Sepax 2 S-100 | 14000 | OAO | Cord Blood Processing System And Storage Container | 2 | Sepax 2 | |
21 | 07640125650402 | FB-100.2b | 10041 | OOF | Cryogenic Cord Blood Storage Container | 2 | CryoSC-Db Freezing Bag | |
22 | 07640125650389 | FB-100.2 | 10032 | OOF | Cryogenic Cord Blood Storage Container | 2 | CryoSC-D Freezing Bag | |
23 | 07640125650273 | CS-570.4mb | 10039 | OAO | Cord Blood Processing System And Storage Container | 2 | Stem Cell Banking-Single-use kits | |
24 | 07640125650259 | CS-570.4 | 10030 | OAO | Cord Blood Processing System And Storage Container | 2 | Stem Cell Banking-Single-use kits | |
25 | 07640125650211 | CS-540.4b | 10037 | OAO | Cord Blood Processing System And Storage Container | 2 | Stem Cell Banking-Single-use kits | |
26 | 07640125650198 | CS-540.4 | 10025 | OAO | Cord Blood Processing System And Storage Container | 2 | Stem Cell Banking-Single-use kits | |
27 | 07640125650174 | CS-530.4b | 10036 | OAO | Cord Blood Processing System And Storage Container | 2 | Stem Cell Banking-Single-use kits | |
28 | 07640125650150 | CS-530.4 | 10024 | OAO | Cord Blood Processing System And Storage Container | 2 | Stem Cell Banking-Single-use kits | |
29 | 07640125650051 | CS-430.1 | 10017 | OAO | Cord Blood Processing System And Storage Container | Stem Cell Banking-Single-use kits | ||
30 | 07640125650341 | FA-200.1 | 10043 | Sepax Kit Accessory | JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | 1 | Double Spike Accessory |
31 | 07640125650136 | CS-530.1 | 10015 | OAO | Cord Blood Processing System And Storage Container | 2 | Sepax single-use kit | |
32 | 07640125650112 | CS-490.1 | 10001 | JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | Sepax single-use kit | ||
33 | 07640125650099 | CS-470.1 | 10005 | JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | 1 | Sepax single-use kit | |
34 | 07640125650037 | AK-101 | 10028 | OAO | Cord Blood Processing System And Storage Container | 2 | Sterile Sampling Line | |
35 | 07640125650013 | AK-100 | 10010 | OAO | Cord Blood Processing System And Storage Container | 2 | Sterile Sampling Line |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00636207314680 | 791-12 | 791-12 | Five Chamber Transfer/Freezing Bag Set intended to be used for cord blood proces Five Chamber Transfer/Freezing Bag Set intended to be used for cord blood processing and freezing | Briostor™ Transfer/Freezing Bag Set | PALL CORPORATION |
2 | 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. | SynGen® DataTrak | THERMOGENESIS CORP. | |
3 | B039SGI04420 | SGI-0442 | CryoPRO™-5 Cryopreservation/Storage Bag Set | CryoPRO™-5 | THERMOGENESIS CORP. | |
4 | B039SGI03050 | SGI-0305 | SynGenX®-1000 Disposable Cartridge | SynGenX®-1000 | THERMOGENESIS CORP. | |
5 | B039SGI0120010 | SGI-0120-01 | SynGenX®-1000 Docking Station | SynGenX®-1000 | THERMOGENESIS CORP. | |
6 | B039SGI00910 | SGI-0091 | CryoPRO™-2 Cryopreservation/Storage Bag Set | CryoPRO™-2 | THERMOGENESIS CORP. | |
7 | B039SGI0046010 | SGI-0046-01 | SynGenX®-1000 Control Module | SynGenX®-1000 | THERMOGENESIS CORP. | |
8 | 07640125650587 | Sepax 2 S-100 | 14000 | Sepax 2 | BIOSAFE S.A. | |
9 | 07640125650570 | CryoSC-Db Seal positioner | 7035 | CryoSC-Db Seal positioner | BIOSAFE S.A. | |
10 | 07640125650563 | CryoSC-D Seal positioner | 7026 | CryoSC-D Seal positioner | BIOSAFE S.A. | |
11 | 07640125650556 | Insertion Tool | 7030 | Insertion Tool | BIOSAFE S.A. | |
12 | 07640125650532 | Metal Storage Canister | 7012 | Metal Storage Canister | BIOSAFE S.A. | |
13 | 07640125650518 | Overwrap Bag | 4085 | Overwrap Bag | BIOSAFE S.A. | |
14 | 07640125650501 | Traceability Labels for Bioarchive | 7031 | Traceability Labels for Bioarchive | BIOSAFE S.A. | |
15 | 07640125650495 | Traceability Labels for cryopreservation | 7011 | Traceability Labels for cryopreservation | BIOSAFE S.A. | |
16 | 07640125650488 | Press Modular | 7040 | Press Modular | BIOSAFE S.A. | |
17 | 07640125650471 | DMSO Vial Adaptator 8 ml | 6089 | DMSO Vial Adaptator 8 ml | BIOSAFE S.A. | |
18 | 07640125650464 | DMSO Vial Adaptator 7 ml | 6076 | DMSO Vial Adaptator 7 ml | BIOSAFE S.A. | |
19 | 07640125650440 | Kit Connector | 7033 | Kit Connector | BIOSAFE S.A. | |
20 | 07640125650433 | Sample Calibrator 0.8 ml | 6074 | Sample Calibrator | BIOSAFE S.A. | |
21 | 07640125650426 | Sample Calibrator 0.3 ml | 6075 | Sample Calibrator | BIOSAFE S.A. | |
22 | 07640125650327 | FA-100.1 | 10022 | Sepax Kit Accessories | DMSO Extension Line | BIOSAFE S.A. |
23 | 07640125650273 | CS-570.4mb | 10039 | Stem Cell Banking-Single-use kits | BIOSAFE S.A. | |
24 | 07640125650259 | CS-570.4 | 10030 | Stem Cell Banking-Single-use kits | BIOSAFE S.A. | |
25 | 07640125650211 | CS-540.4b | 10037 | Stem Cell Banking-Single-use kits | BIOSAFE S.A. | |
26 | 07640125650198 | CS-540.4 | 10025 | Stem Cell Banking-Single-use kits | BIOSAFE S.A. | |
27 | 07640125650174 | CS-530.4b | 10036 | Stem Cell Banking-Single-use kits | BIOSAFE S.A. | |
28 | 07640125650150 | CS-530.4 | 10024 | Stem Cell Banking-Single-use kits | BIOSAFE S.A. | |
29 | 07640125650136 | CS-530.1 | 10015 | Sepax single-use kit | BIOSAFE S.A. | |
30 | 07640125650051 | CS-430.1 | 10017 | Stem Cell Banking-Single-use kits | BIOSAFE S.A. | |
31 | 07640125650037 | AK-101 | 10028 | Sterile Sampling Line | BIOSAFE S.A. | |
32 | 07640125650013 | AK-100 | 10010 | Sterile Sampling Line | BIOSAFE S.A. | |
33 | 00886368001015 | 80088 | PXP Disposable Cartridge | PXP | THERMOGENESIS CORP. | |
34 | 00886368000971 | 80088 | PXP Disposable Cartridge | PXP | THERMOGENESIS CORP. | |
35 | 00886368000964 | 80087 | PXP Disposable Cartridge | PXP | THERMOGENESIS CORP. | |
36 | 00886368000711 | 80063 | PXP Disposable Cartridge | PXP | THERMOGENESIS CORP. | |
37 | 00886368000650 | 80066 | PXP Docking Station | PXP | THERMOGENESIS CORP. | |
38 | 00886368000636 | 80065 | PXP Control Module | PXP | THERMOGENESIS CORP. | |
39 | 00886368000582 | 8-4000-1 | BioArchive Device 220V | Thermogenesis BioArchive | THERMOGENESIS CORP. | |
40 | 00886368000568 | 8-5144 | 8-5144 | AutoXpress Platform Counterbalance CG | THERMOGENESIS CORP. | |
41 | 00886368000544 | 8-5100 | Thermogenesis Start Up Accessory Kit, AXP | Thermogenesis Start Up Accessory Kit, AXP | THERMOGENESIS CORP. | |
42 | 00886368000537 | 8-5148 | 8-5148 | AXP Accessory | Component Retaining Clip Set, AXP | THERMOGENESIS CORP. |
43 | 00886368000520 | 8-5104 | 8-5104 | AXP Accessory | Counterweight, AXP | THERMOGENESIS CORP. |
44 | 00886368000513 | 7-00-288 | 7-00-288 | AXP Accessory | Xpresstrak Software Kit | THERMOGENESIS CORP. |
45 | 00886368000445 | 8-5114 | 8-5114 | AXP Adapter Set, Sorvall 11754/11297 | THERMOGENESIS CORP. | |
46 | 00886368000438 | 8-5155 | 8-5155 | AXP Sorval 11754 Bucket Pads | THERMOGENESIS CORP. | |
47 | 00886368000421 | 8-5113 | 8-5113 | AXP Adapter, 101-102mm Round Bucket | THERMOGENESIS CORP. | |
48 | 00886368000414 | 8-5112 | 8-5112 | AXP Large Oval Bucket Adapter Set | THERMOGENESIS CORP. | |
49 | 00886368000407 | 8-5105 | 8-5105 | AXP Medium Oval Bucket Adapter Set | THERMOGENESIS CORP. | |
50 | 00886368000377 | 8-5100 | 8-5100 | Start-up kit for the AXP System | AXP Start Up Accessory Kit | THERMOGENESIS CORP. |