Stat Profile Phox Plus
by Nova Biomedical Corporation 8 variants
Stat Profile Phox Plus (27613) is a Class II device made by Nova Biomedical Corporation, cleared under FDA 510(k) K002613 on 19 Oct 2000 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 00385480276139), 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 | Number00385480276139 | Date20 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK002613 | Date19 Oct 2000 | StatusActive |
Official records
- AccessGUDID record 00385480276139
- FDA 510(k) database K002613
Across registries
- FDA 510(k) K002613 decided 19 Oct 2000 Active
- FDA GUDID UDI-DI 00385480276139 listed 20 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K002613
- Listed FDA GUDID 00385480276139
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- Withdrawn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, calibrator
- Model / Ref / Catalog
- PHOX PLUS, 27613
- Primary DI / UDI-DI
- 00385480276139
- 510(k) Number
- FDA product code
- JIX
- GMDN term
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator
- Device class
- Class II
- Regulation number
- 862.1150
- GUDID distribution status
- In Commercial Distribution
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