Identity
- Trade Name
- BHI BROTH 250mL EUDAMEDPRAS Brain Heart Infusion Broth (BHI BROTH) FDA UDI
- Generic Name
- Enriched broth culture medium IVD FDA UDI
- Device Name
- Anaerobic Culture Media EUDAMEDAS-8722 Brain Heart Infusion Broth (BHI BROTH) is an enriched non-selective media intended for the cultivation of most anaerobic bacteria and other fastidious microorganisms. Pre-reduced anaerobically sterilized (PRAS). 250 mL fill volume. 250 mL Pyrex bottle. Transparent golden yellow liquid. 1 bottle per pack. FDA UDI
- Model / Reference
- AS-8722 EUDAMEDFDA UDI
- Description
- AS-8722 Brain Heart Infusion Broth (BHI BROTH) is an enriched non-selective media intended for the cultivation of most anaerobic bacteria and other fastidious microorganisms. Pre-reduced anaerobically sterilized (PRAS). 250 mL fill volume. 250 mL Pyrex bottle. Transparent golden yellow liquid. 1 bottle per pack. FDA UDI
Identifiers
- Catalog Number
- AS-8722 FDA UDI
- Primary DI / UDI-DI
- 00810048901111 EUDAMEDFDA UDI
- Basic UDI-DI
- 081004890ANAEROBEDT EUDAMED
- FDA Product Code
- JSG FDA UDI
- EMDN Code
- W0104010306 CULTURE MEDIA IN BOTTLES EUDAMED
- GMDN Term
- Enriched broth culture medium IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2300 FDA UDI
- Market of Registration
- Netherlands 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
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
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
BHI BROTH 250mL by Anaerobe Systems — 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 | 081004890ANAEROBEDT | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Anaerobe Systems
- EUDAMED SRN
- US-MF-000040030
- Authorised Representative
- Casus Europe B.V. NL-AR-000037688
Sources (2)
- EUDAMED 5c601b05-9855-4a19-85d4-17f1ae65ea24 61 fields · synced Jun 17, 2026
- FDA UDI b23b04d9-d88a-4e4b-b121-c8c54aaff8d6 36 fields · synced May 29, 2026