Identity
- Trade Name
- TheraPEAK™ X-VIVO™ 15 w/o Gent or PR, 1L FDA UDI
- Generic Name
- Ex vivo cell culture medium FDA UDI
- Model / Reference
- BP04-744Q FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05407010122848 FDA UDI
- FDA Product Code
- JCF FDA UDI
- GMDN Term
- Ex vivo cell culture medium FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.8500 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
TheraPEAK™ X-VIVO™ 15 w/o Gent or PR, 1L by Lonza Verviers — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Lonza Verviers
Sources (1)
- FDA UDI cf4f6db2-866d-466b-9782-29a177f9c8d0 33 fields · synced Jun 8, 2026