Identity
- Trade Name
- Phoenix EUDAMEDBD Phoenix™ EMERGE™ AST Indicator Solution FDA UDI
- Generic Name
- Multiple antibacterial minimum inhibitory concentration (MIC) IVD, reagent FDA UDI
- Device Name
- BD Phoenix™ EMERGE™ AST Indicator Solution EUDAMEDFDA UDI
- Model / Reference
- 246015 EUDAMEDFDA UDI
- Description
- BD Phoenix™ Emerge™ AST Indicator Solution FDA UDI
Identifiers
- Catalog Number
- 246015 FDA UDI
- Primary DI / UDI-DI
- 30382902460153 EUDAMEDFDA UDI
- Basic UDI-DI
- 038290KPWSRPLKP7 EUDAMED
- Unit of Use DI
- 00382902460152 EUDAMED
- 510(k) Number
- K020321 FDA UDI
- FDA Product Code
- LON FDA UDI
- EMDN Code
- W0104080113 OTHER AUTOMATED SUSCEPTIBILITY TESTING (INCL CONSUMABLES...) EUDAMED
- GMDN Term
- Multiple antibacterial minimum inhibitory concentration (MIC) IVD, reagent FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 866.1645 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
No
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 — 6 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 | 038290KPWSRPLKP7 | 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 87d301f1-0c06-4b53-8eb7-6bffe829a455 61 fields · synced Jun 9, 2026
- FDA UDI 495b72c0-27c9-4198-b645-72d095fdafcd 38 fields · synced May 30, 2026