Identity
- Trade Name
- STAT PROFILE FDA UDI
- Generic Name
- Blood gas analyser IVD, point-of-care FDA UDI
- Device Name
- Stat Profile pHOx Ultra ABG Analyzer FDA UDI
- Model / Reference
- PHOX ULTRA FDA UDI
- Description
- Stat Profile pHOx Ultra ABG Analyzer FDA UDI
Identifiers
- Catalog Number
- 42014 FDA UDI
- Primary DI / UDI-DI
- 00385480420143 FDA UDI
- 510(k) Number
- K110648 FDA UDI
- FDA Product Code
- JFP FDA UDICFA FDA UDIGGZ FDA UDICGL FDA UDIGLY FDA UDICHL FDA UDICGZ FDA UDIGKK FDA UDICDS FDA UDIJJB FDA UDIJIX FDA UDINGD FDA UDIJGS FDA UDICEM FDA UDICGA FDA UDIBXX FDA UDIGHS FDA UDIGJC FDA UDI
- GMDN Term
- Blood gas analyser IVD, point-of-care FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1145 FDA UDI862.1495 FDA UDI864.7500 FDA UDI862.1225 FDA UDI862.1120 FDA UDI862.1170 FDA UDI862.1770 FDA UDI862.1115 FDA UDI862.1150 FDA UDI862.1450 FDA UDI862.1665 FDA UDI862.1600 FDA UDI862.1345 FDA UDI868.2620 FDA UDI864.7425 FDA UDI864.7490 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Blood gas analyser IVD, point-of-care
Stat Profile by Nova Biomedical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K110648 also covers:
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nova Biomedical Corporation
Sources (1)
- FDA UDI 6d42a07c-cd6d-43cd-9040-1bbd242b322d 37 fields · synced Jun 8, 2026