Identity
- Trade Name
- BD Phoenix™ NMIC/ID-130 FDA UDI
- Generic Name
- Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent FDA UDI
- Device Name
- BD Phoenix™ NMIC/ID-130 FDA UDI
- Model / Reference
- 448730 FDA UDI
- Description
- BD Phoenix™ NMIC/ID-130 FDA UDI
Identifiers
- Catalog Number
- 448730 FDA UDI
- Primary DI / UDI-DI
- 30382904487301 FDA UDI
- 510(k) Number
- K020322 FDA UDIK023444 FDA UDIK023634 FDA UDIK023858 FDA UDIK031429 FDA UDIK031530 FDA UDIK031699 FDA UDIK032153 FDA UDIK032275 FDA UDIK032299 FDA UDIK032655 FDA UDIK033362 FDA UDIK033458 FDA UDIK041384 FDA UDIK042932 FDA UDIK043389 FDA UDIK052269 FDA UDIK060217 FDA UDIK060444 FDA UDIK060447 FDA UDIK061327 FDA UDIK061355 FDA UDIK062207 FDA UDIK062944 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-130 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:
K023444 also covers:
K023634 also covers:
K023858 also covers:
K031530 also covers:
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K032299 also covers:
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K062944 also covers:
K063301 also covers:
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K063811 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 71388a23-9551-4418-a6cf-9da883158361 38 fields · synced Jun 1, 2026