BD BACTEC™ Standard Anaerobic/F Culture Vials
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- BACTEC EUDAMEDBD BACTEC™ Standard Anaerobic/F Culture Vials FDA UDI
- Generic Name
- Culture medium antimicrobial supplement IVD FDA UDI
- Device Name
- BD BACTEC™ Standard Anaerobic/F Culture Vials EUDAMEDBD BACTEC™ Standard Anaerobic/F Culture Vials, case of 50 vials FDA UDI
- Model / Reference
- 442024 EUDAMEDFDA UDI
- Description
- BD BACTEC™ Standard Anaerobic/F Culture Vials, case of 50 vials FDA UDI
Identifiers
- Catalog Number
- 442024 FDA UDI
- Primary DI / UDI-DI
- 30382904420247 EUDAMEDFDA UDI
- Basic UDI-DI
- 038290QUBVRAMJKL EUDAMED
- Unit of Use DI
- 00382904420246 EUDAMED
- 510(k) Number
- K161306 FDA UDI
- FDA Product Code
- MDB FDA UDI
- EMDN Code
- W0104010504 BOTTLES FOR AUTOMATED BLOOD CULTURE EUDAMED
- GMDN Term
- Culture medium antimicrobial supplement IVD FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2560 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
Yes
Human Tissues
No
Animal Tissues
Yes
Microbial Substances
Yes
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Total Volume — 40 Milliliter FDA UDI
Category: Culture medium antimicrobial supplement IVD
BD BACTEC™ Standard Anaerobic/F Culture Vials by Becton Dickinson And Company — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Becton Dickinson And Company
Sources (2)
- FDA UDI 28f34b4a-c7e7-42f5-bd03-a87c82294040 38 fields · synced Oct 8, 2026
- EUDAMED b8926cb8-b3c2-4445-9050-d3f35244c452 61 fields · synced Oct 7, 2026