Identity
- Trade Name
- BBL EUDAMEDBD BBL™ Brain Heart Infusion FDA UDI
- Generic Name
- Basic/simple nutrient broth culture medium IVD FDA UDI
- Device Name
- BD BBL™ Brain Heart Infusion, 8 mL, BD BBL™ Brain Heart Infusion, 5 mL of 10 size K tubes and BD BBL™ Brain Heart Infusion, 5 mL of 100 size K tubes EUDAMEDBD BBL™ Brain Heart Infusion FDA UDI
- Model / Reference
- 220837 EUDAMEDFDA UDI
- Description
- BD BBL™ Brain Heart Infusion FDA UDI
Identifiers
- Catalog Number
- 220837 FDA UDI
- Primary DI / UDI-DI
- 30382902208373 EUDAMEDFDA UDI
- Basic UDI-DI
- 038290ISVNMBONJN EUDAMED
- Unit of Use DI
- 00382902208372 EUDAMED
- FDA Product Code
- JSC FDA UDI
- EMDN Code
- W0104010206 MEDIA IN TUBES (SOLID & LIQUID) EUDAMED
- GMDN Term
- Basic/simple nutrient broth culture medium IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2350 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
Yes
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
- Total Volume — 8 Milliliter 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 | 038290ISVNMBONJN | 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 93948b9b-c91c-40e3-9665-8b2c23303705 61 fields · synced Oct 6, 2026
- FDA UDI 46705ef0-05b7-4a86-bcdc-145e8950000a 37 fields · synced May 30, 2026