Identity
- Trade Name
- BD Phoenix™ NMIC/ID-302 FDA UDI
- Generic Name
- Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent FDA UDI
- Device Name
- BD Phoenix™ NMIC/ID-302 FDA UDI
- Model / Reference
- 448741 FDA UDI
- Description
- BD Phoenix™ NMIC/ID-302 FDA UDI
Identifiers
- Catalog Number
- 448741 FDA UDI
- Primary DI / UDI-DI
- 30382904487417 FDA UDI
- 510(k) Number
- K020322 FDA UDIK023444 FDA UDIK023634 FDA UDIK023858 FDA UDIK024153 FDA UDIK031530 FDA UDIK031699 FDA UDIK032299 FDA UDIK032567 FDA UDIK032655 FDA UDIK032675 FDA UDIK033458 FDA UDIK033558 FDA UDIK033560 FDA UDIK041384 FDA UDIK042932 FDA UDIK060214 FDA UDIK060257 FDA UDIK060444 FDA UDIK060447 FDA UDIK061355 FDA UDIK061867 FDA UDIK062944 FDA UDIK063301 FDA UDIK063573 FDA UDIK063811 FDA UDIK063824 FDA UDIK071623 FDA UDIK123266 FDA UDIK123404 FDA UDIK132674 FDA UDIK151320 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
- 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
Category: Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
BD Phoenix™ NMIC/ID-302 by Becton Dickinson And Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K020322 also covers:
K023444 also covers:
K023634 also covers:
K023858 also covers:
K024153 also covers:
K031530 also covers:
K031699 also covers:
K032299 also covers:
K032567 also covers:
K032655 also covers:
K032675 also covers:
K033458 also covers:
K033560 also covers:
K041384 also covers:
K042932 also covers:
K060214 also covers:
K060257 also covers:
K060444 also covers:
K060447 also covers:
K061355 also covers:
K062944 also covers:
K063301 also covers:
K063573 also covers:
K063811 also covers:
K063824 also covers:
K071623 also covers:
K123266 also covers:
K123404 also covers:
K132674 also covers:
K151320 also covers:
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 44176321-6015-464b-971e-d55f15a259a7 37 fields · synced May 30, 2026