STAT PROFILE phox plus L
by Nova Biomedical Corporation 7 variants
STAT PROFILE phox plus L (34117) is a Class I device made by Nova Biomedical Corporation, cleared under FDA 510(k) K023567 on 20 Dec 2002 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 00385480341172), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00385480341172 | Date16 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK023567 | Date20 Dec 2002 | StatusActive |
Official records
- AccessGUDID record 00385480341172
- FDA 510(k) database K023567
Across registries
- FDA 510(k) K023567 decided 20 Dec 2002 Active
- FDA GUDID UDI-DI 00385480341172 listed 16 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K023567
- Listed FDA GUDID 00385480341172
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Stat Profile
- Generic name
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
- Model / Ref / Catalog
- phox plus L, 34117
- Primary DI / UDI-DI
- 00385480341172
- 510(k) Number
- FDA product code
- JJY
- GMDN term
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
- Device class
- Class I
- Regulation number
- 862.1660
- GUDID distribution status
- In Commercial Distribution
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