Identity
- Trade Name
- RPMI 1640 W/GLUT. & GENTAM., 500 ml bot FDA UDI
- Generic Name
- Ex vivo cell culture medium FDA UDI
- Model / Reference
- 04-1055F FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840075401049 FDA UDI
- FDA Product Code
- KIT FDA UDI
- GMDN Term
- Ex vivo cell culture medium FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.2220 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Category: Ex vivo cell culture medium
RPMI 1640 W/GLUT. & GENTAM., 500 ml bot by Lonza Walkersville, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 Walkersville, Inc.
Sources (1)
- FDA UDI 3b57c2b1-36a8-4a2d-936e-9b1a6146070e 32 fields · synced Jun 8, 2026