Identity
- Trade Name
- BD Phoenix™ NMIC/ID-134 FDA UDI
- Generic Name
- Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent FDA UDI
- Device Name
- BD Phoenix™ NMIC/ID-134 FDA UDI
- Model / Reference
- 448734 FDA UDI
- Description
- BD Phoenix™ NMIC/ID-134 FDA UDI
Identifiers
- Catalog Number
- 448734 FDA UDI
- Primary DI / UDI-DI
- 30382904487349 FDA UDI
- 510(k) Number
- K020322 FDA UDIK023634 FDA UDIK023858 FDA UDIK031429 FDA UDIK031530 FDA UDIK031699 FDA UDIK031912 FDA UDIK032153 FDA UDIK032299 FDA UDIK032567 FDA UDIK033458 FDA UDIK033557 FDA UDIK041384 FDA UDIK042932 FDA UDIK043389 FDA UDIK052269 FDA UDIK060217 FDA UDIK060257 FDA UDIK060447 FDA UDIK061327 FDA UDIK061355 FDA UDIK062207 FDA UDIK062687 FDA UDIK062945 FDA UDIK063301 FDA UDIK063573 FDA UDIK063811 FDA UDIK063824 FDA UDI
- FDA Product Code
- LON FDA UDI
- GMDN Term
- Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.1645 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
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
BD Phoenix™ NMIC/ID-134 by Becton Dickinson And Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K020322 also covers:
K023634 also covers:
K023858 also covers:
K031530 also covers:
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K032299 also covers:
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Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Becton Dickinson And Company
Sources (1)
- FDA UDI c92cce64-1841-4e01-a8bc-ffff8d7e3edb 38 fields · synced May 30, 2026