Identity
- Trade Name
- REMEL FDA UDI
- Generic Name
- Culture medium antimicrobial supplement IVD FDA UDI
- Device Name
- OADC Enrichment (2ml) PK/10 FDA UDI
- Model / Reference
- R450600 FDA UDI
- Description
- OADC Enrichment (2ml) PK/10 FDA UDI
Identifiers
- Catalog Number
- R450600 FDA UDI
- Primary DI / UDI-DI
- 00848838031922 FDA UDI
- FDA Product Code
- JSK FDA UDI
- GMDN Term
- Culture medium antimicrobial supplement IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.2450 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Remel by Remel, Inc. — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Remel, Inc.
Sources (1)
- FDA UDI 91da1045-5682-4c12-ab4c-a2e45ae4850f 35 fields · synced Jun 8, 2026