ThermoGenesis AXP
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- AXP EUDAMEDThermoGenesis AXP FDA UDI
- Generic Name
- Blood centrifugation system containment kit FDA UDI
- Device Name
- AXP II Device EUDAMEDFDA UDIAXP II Refurbished Device FDA UDI
- Model / Reference
- 80056 EUDAMEDFDA UDIAXP II Device EUDAMED80056-RFB FDA UDI
- Description
- AXP II Refurbished Device FDA UDIAXP II Device FDA UDI
Identifiers
- Catalog Number
- 80056-RFB FDA UDI80056 FDA UDI
- Primary DI / UDI-DI
- 10886368000619 EUDAMEDFDA UDI00886368000001 FDA UDI
- Basic UDI-DI
- 088636AXPIICMES EUDAMED
- Direct Marketing DI
- 00886368000612 EUDAMED
- FDA Product Code
- OAO FDA UDI
- EMDN Code
- B030203 SINGLE PLASMA COMPONENTS REMOVAL DEVICES AND KITS EUDAMED
- GMDN Term
- Blood centrifugation system containment kit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 864.9900 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Blood centrifugation system containment kit
ThermoGenesis AXP by Thermogenesis Corp. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
BK180198 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Thermogenesis Corp.
Sources (3)
- FDA UDI f23aa203-40d5-4c72-aef3-f8a85492fb16 36 fields · synced Jul 11, 2026
- FDA UDI 2fddeb07-43cb-48d6-b556-3889f2fa3414 37 fields · synced May 30, 2026
- EUDAMED 9827c6e3-7ef5-4e5e-935e-d402fabbb573 61 fields · synced Jul 11, 2026