Identity
- Trade Name
- Phoenix EUDAMEDBD Phoenix™ AP ID Broth FDA UDI
- Generic Name
- Buffered isotonic saline reagent IVD FDA UDI
- Device Name
- BD Phoenix™ AP ID Broth EUDAMEDFDA UDI
- Model / Reference
- 448012 EUDAMEDFDA UDI
- Description
- BD Phoenix™ AP ID Broth FDA UDI
Identifiers
- Catalog Number
- 448012 FDA UDI
- Primary DI / UDI-DI
- 30382904480128 EUDAMEDFDA UDI
- Basic UDI-DI
- 038290WODQBNHBGM EUDAMED
- Unit of Use DI
- 00382904480127 EUDAMED
- FDA Product Code
- JSG FDA UDI
- EMDN Code
- W0104080112 OTHER AUTOMATED IDENTIFICATION TESTING (INCL. CONSUMABLES...) EUDAMED
- GMDN Term
- Buffered isotonic saline reagent 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
No
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
- Total Volume — 800 Milliliter FDA UDI
Phoenix 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 | 038290WODQBNHBGM | 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 06cdd120-f718-48a6-ad54-f19da4968a54 61 fields · synced Oct 7, 2026
- FDA UDI d0ea64d8-703c-4ba8-8a70-851a764e4782 37 fields · synced May 29, 2026