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 | 00886368000551 | 8-5142 | Thermogenesis Start Up Accessory Kit, MarrowXpress | JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | 1 | Thermogenesis Start Up Accessory Kit, MarrowXpress | |
17 | 00886368000421 | 8-5113 | 8-5113 | OAO | Cord Blood Processing System And Storage Container | 2 | AXP Adapter, 101-102mm Round Bucket | |
18 | 00886368000414 | 8-5112 | 8-5112 | OAO | Cord Blood Processing System And Storage Container | 2 | AXP Large Oval Bucket Adapter Set | |
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 | 00886368001015 | 80088 | PXP Disposable Cartridge | PXP | THERMOGENESIS CORP. | |
2 | 00886368000971 | 80088 | PXP Disposable Cartridge | PXP | THERMOGENESIS CORP. | |
3 | 00886368000964 | 80087 | PXP Disposable Cartridge | PXP | THERMOGENESIS CORP. | |
4 | 00886368000711 | 80063 | PXP Disposable Cartridge | PXP | THERMOGENESIS CORP. | |
5 | 00886368000650 | 80066 | PXP Docking Station | PXP | THERMOGENESIS CORP. | |
6 | 00886368000636 | 80065 | PXP Control Module | PXP | THERMOGENESIS CORP. | |
7 | 00886368000582 | 8-4000-1 | BioArchive Device 220V | Thermogenesis BioArchive | THERMOGENESIS CORP. | |
8 | 00886368000568 | 8-5144 | 8-5144 | AutoXpress Platform Counterbalance CG | THERMOGENESIS CORP. | |
9 | 00886368000544 | 8-5100 | Thermogenesis Start Up Accessory Kit, AXP | Thermogenesis Start Up Accessory Kit, AXP | THERMOGENESIS CORP. | |
10 | 00886368000537 | 8-5148 | 8-5148 | AXP Accessory | Component Retaining Clip Set, AXP | THERMOGENESIS CORP. |
11 | 00886368000520 | 8-5104 | 8-5104 | AXP Accessory | Counterweight, AXP | THERMOGENESIS CORP. |
12 | 00886368000513 | 7-00-288 | 7-00-288 | AXP Accessory | Xpresstrak Software Kit | THERMOGENESIS CORP. |
13 | 00886368000445 | 8-5114 | 8-5114 | AXP Adapter Set, Sorvall 11754/11297 | THERMOGENESIS CORP. | |
14 | 00886368000438 | 8-5155 | 8-5155 | AXP Sorval 11754 Bucket Pads | THERMOGENESIS CORP. | |
15 | 00886368000421 | 8-5113 | 8-5113 | AXP Adapter, 101-102mm Round Bucket | THERMOGENESIS CORP. | |
16 | 00886368000414 | 8-5112 | 8-5112 | AXP Large Oval Bucket Adapter Set | THERMOGENESIS CORP. | |
17 | 00886368000407 | 8-5105 | 8-5105 | AXP Medium Oval Bucket Adapter Set | THERMOGENESIS CORP. | |
18 | 00886368000377 | 8-5100 | 8-5100 | Start-up kit for the AXP System | AXP Start Up Accessory Kit | THERMOGENESIS CORP. |
19 | 00886368000360 | 8-5103 | 8-5103 | Cord blood processing system docking station | AXP Docking Station | THERMOGENESIS CORP. |
20 | 00886368000346 | 8-5102 | 8-5102 | Cord blood processing system | AXP Device | THERMOGENESIS CORP. |
21 | 00886368000322 | 70176 | 8-5110 | Utilized for quality control testing of the AXP Device. | QC Bagset | THERMOGENESIS CORP. |
22 | 00886368000308 | 8-5101 | Cord blood processing system and storage container | AXP Disposable Processing Bagset | THERMOGENESIS CORP. | |
23 | 00886368000223 | 80122 | PXP-LAVARE Docking Station, packaged | PXP-LAVARE | THERMOGENESIS CORP. | |
24 | 00886368000216 | 80121 | PXP-LAVARE Control Module, packaged | PXP-LAVARE | THERMOGENESIS CORP. | |
25 | 00886368000209 | 80120 | PXP-LAVARE Disposable Cartridge | PXP-LAVARE | THERMOGENESIS CORP. | |
26 | 00886368000193 | 80118 | PXP-LAVARE Disposable Cartridge | PXP-LAVARE | THERMOGENESIS CORP. | |
27 | 00886368000186 | 80118 | PXP-LAVARE Disposable Cartridge | PXP-LAVARE | THERMOGENESIS CORP. | |
28 | 00886368000124 | 80102 | PXP-1000 Disposable Cartridge | PXP-1000 | THERMOGENESIS CORP. | |
29 | 00886368000117 | 80102 | PXP-1000 Disposable Cartridge | PXP-1000 | THERMOGENESIS CORP. | |
30 | 00886368000100 | 80101 | PXP-1000 Disposable Cartridge | PXP-1000 | THERMOGENESIS CORP. | |
31 | 00886368000094 | 80100 | PXP-1000 Disposable Cartridge | PXP-1000 | THERMOGENESIS CORP. | |
32 | 00886368000070 | 80103 | PXP-1000 Docking Station | PXP-1000 Docking Station | THERMOGENESIS CORP. | |
33 | 00886368000056 | 80104 | PXP-1000 Control Module | PXP-1000 | THERMOGENESIS CORP. | |
34 | 00861880000333 | PCB500 | The PrepaCyte-CB (Cord Blood) Processing System is intended for use in cell proc The PrepaCyte-CB (Cord Blood) Processing System is intended for use in cell processing laboratories to process and store total nucleated cells (TNC) from human umbilical cord blood | PrepaCyte-CB 500 | CRYO-CELL INTERNATIONAL, INC. | |
35 | 00861880000326 | PCB2100-270 | P/N PCB2100-270 | The PrepaCyte CB (Cord Blood) Processing System is intended for use in cell proc The PrepaCyte CB (Cord Blood) Processing System is intended for use in cell processing laboratories to process and store total nucleated cells (TNC) from human umbilical cord blood, prior to banking. The device is composed of two integrally-attached processing and storage containers (or a single processing container) with separation media. | PrepaCyte-CB | CRYO-CELL INTERNATIONAL, INC. |
36 | 00861880000319 | PCB150 | P/N PCB150 | Indications for Use: The PrepaCyte-CB (Cord Blood) Processing System is intended Indications for Use: The PrepaCyte-CB (Cord Blood) Processing System is intended for use in cell processing laboratories to process and store total nucleated cells (TNC) from human umbilical cord blood, prior to banking. The device is composed of three integrally-attached processing and storage containers (or a single processing container) with separation media. | PrepaCyte-CB | CRYO-CELL INTERNATIONAL, INC. |
37 | 00861880000302 | PCB1100 | P/N PCB1100 | Indications for Use: The PrepaCyte-CB (Cord Blood) Processing System is intended Indications for Use: The PrepaCyte-CB (Cord Blood) Processing System is intended for use in cell processing laboratories to process and store total nucleated cells (TNC) from human umbilical cord blood, prior to banking. The device is composed of three integrally-attached processing and storage containers (or a single processing container) with separation media. | PrepaCyte-CB | CRYO-CELL INTERNATIONAL, INC. |
38 | 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 |
39 | 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. | |
40 | B039SGI04420 | SGI-0442 | CryoPRO™-5 Cryopreservation/Storage Bag Set | CryoPRO™-5 | THERMOGENESIS CORP. | |
41 | B039SGI03050 | SGI-0305 | SynGenX®-1000 Disposable Cartridge | SynGenX®-1000 | THERMOGENESIS CORP. | |
42 | B039SGI0120010 | SGI-0120-01 | SynGenX®-1000 Docking Station | SynGenX®-1000 | THERMOGENESIS CORP. | |
43 | B039SGI00910 | SGI-0091 | CryoPRO™-2 Cryopreservation/Storage Bag Set | CryoPRO™-2 | THERMOGENESIS CORP. | |
44 | B039SGI0046010 | SGI-0046-01 | SynGenX®-1000 Control Module | SynGenX®-1000 | THERMOGENESIS CORP. | |
45 | 07640125650587 | Sepax 2 S-100 | 14000 | Sepax 2 | BIOSAFE S.A. | |
46 | 07640125650570 | CryoSC-Db Seal positioner | 7035 | CryoSC-Db Seal positioner | BIOSAFE S.A. | |
47 | 07640125650563 | CryoSC-D Seal positioner | 7026 | CryoSC-D Seal positioner | BIOSAFE S.A. | |
48 | 07640125650556 | Insertion Tool | 7030 | Insertion Tool | BIOSAFE S.A. | |
49 | 07640125650532 | Metal Storage Canister | 7012 | Metal Storage Canister | BIOSAFE S.A. | |
50 | 07640125650518 | Overwrap Bag | 4085 | Overwrap Bag | BIOSAFE S.A. |