Identity
- Trade Name
- BBL EUDAMEDBD BBL™ Schaedler Broth with Vitamin K1 FDA UDI
- Generic Name
- Differential/selective broth culture medium IVD FDA UDI
- Device Name
- BD BBL™ Schaedler Brothwith Vitamin K1 EUDAMEDBD BBL™ Schaedler Broth with Vitamin K1, Carton of 100 size K tubes FDA UDI
- Model / Reference
- 221542 EUDAMEDFDA UDI
- Description
- BD BBL™ Schaedler Broth with Vitamin K1, Carton of 100 size K tubes FDA UDI
Identifiers
- Catalog Number
- 221542 FDA UDI
- Primary DI / UDI-DI
- 30382902215425 EUDAMEDFDA UDI
- Basic UDI-DI
- 038290JVNDZNHMJ6 EUDAMED
- Unit of Use DI
- 00382902215424 EUDAMED
- FDA Product Code
- JSG FDA UDI
- EMDN Code
- W0104010206 MEDIA IN TUBES (SOLID & LIQUID) EUDAMED
- GMDN Term
- Differential/selective broth culture medium IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2300 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 | 038290JVNDZNHMJ6 | 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 ad7e5395-8a4e-40d9-98ce-f778433adca9 61 fields · synced Oct 6, 2026
- FDA UDI 01e1d9f7-499c-4f86-991a-f34d0c74a8db 37 fields · synced May 29, 2026