Identity
- Trade Name
- BBL EUDAMEDBD BBL™ Columbia Agar with 5% Sheep Blood FDA UDI
- Generic Name
- Enriched agar culture medium IVD FDA UDI
- Device Name
- BD BBL™ Columbia Agar with 5% Sheep Blood EUDAMEDBD BBL™ Columbia Agar with 5% Sheep Blood, Carton of 100 plates FDA UDI
- Model / Reference
- 221263 EUDAMEDFDA UDI
- Description
- BD BBL™ Columbia Agar with 5% Sheep Blood, Carton of 100 plates FDA UDI
Identifiers
- Catalog Number
- 221263 FDA UDI
- Primary DI / UDI-DI
- 10382902212635 EUDAMEDFDA UDI
- Basic UDI-DI
- 038290GZRIOOPRLN EUDAMED
- Unit of Use DI
- 00382902212638 EUDAMED
- FDA Product Code
- KZI FDA UDI
- EMDN Code
- W0104010405 NON-CHROMOGENIC MEDIA (PLATES) EUDAMED
- GMDN Term
- Enriched agar culture medium IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2330 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
Yes
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
Dimensions & Sizes
- Size
- Outer Diameter — 100 Millimeter FDA UDIDepth — 15 Millimeter FDA UDI
Bbl by Becton, Dickinson and Company — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 038290GZRIOOPRLN | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
- EUDAMED SRN
- US-MF-000018910
- Authorised Representative
- Becton Dickinson Ireland Limited IE-AR-000007610
Sources (2)
- EUDAMED 65f4f77b-eb78-42b4-8e39-3590c9c85952 61 fields · synced Oct 6, 2026
- FDA UDI df70acf7-c75e-4269-816f-66766c2dc277 37 fields · synced May 30, 2026