Identity
- Trade Name
- AXP Start Up Accessory Kit FDA UDI
- Generic Name
- Cryobiological storage container FDA UDI
- Device Name
- Start-up kit for the AXP System FDA UDI
- Model / Reference
- 8-5100 FDA UDI
- Description
- Start-up kit for the AXP System FDA UDI
Identifiers
- Catalog Number
- 8-5100 FDA UDI
- Primary DI / UDI-DI
- 00886368000377 FDA UDI
- FDA Product Code
- OAO FDA UDI
- GMDN Term
- Cryobiological storage container FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9900 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cryobiological storage container
AXP Start Up Accessory Kit by Thermogenesis Corp. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Cryobiological storage container.
- AXP Large Oval Bucket Adapter Set — Thermogenesis Corp. · Class II
- AXP Adapter Set, Sorvall 11754/11297 — Thermogenesis Corp. · Class II
- AXP Medium Oval Bucket Adapter Set — Thermogenesis Corp. · Class II
- Counterweight, AXP — Thermogenesis Corp. · Class II
- 3D Bag Set — Thermogenesis Corp. · Class I
- AXP Sorval 11754 Bucket Pads — Thermogenesis Corp. · Class II
- AutoXpress Platform Counterbalance CG — Thermogenesis Corp. · Class II
- AXP Adapter, 101-102mm Round Bucket — Thermogenesis Corp. · Class II
Cleared under the same submission
BK070006 also covers:
- AXP Adapter Set, Sorvall 11754/11297 — Thermogenesis Corp.
- AXP Adapter, 101-102mm Round Bucket — Thermogenesis Corp.
- AXP Large Oval Bucket Adapter Set — Thermogenesis Corp.
- AXP Medium Oval Bucket Adapter Set — Thermogenesis Corp.
- AXP Sorval 11754 Bucket Pads — Thermogenesis Corp.
- AutoXpress Platform Counterbalance CG — Thermogenesis Corp.
- Component Retaining Clip Set, AXP — Thermogenesis Corp.
- Counterweight, AXP — Thermogenesis Corp.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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 (2)
- FDA UDI d474ed03-07b8-4da0-a209-da57eca31ebc 36 fields · synced Jun 17, 2026
- EUDAMED 1 fields · synced Jun 3, 2026