Identity
- Trade Name
- STAT PROFILE FDA UDI
- Generic Name
- Blood gas analyser IVD, point-of-care FDA UDI
- Device Name
- Prime ABG w/ Scanner Analyzer FDA UDI
- Model / Reference
- PRIME ABG FDA UDI
- Description
- Prime ABG w/ Scanner Analyzer FDA UDI
Identifiers
- Catalog Number
- 53655 FDA UDI
- Primary DI / UDI-DI
- 00385480536554 FDA UDI
- 510(k) Number
- K151982 FDA UDI
- FDA Product Code
- CHL FDA UDIJJX FDA UDIJJS FDA UDI
- GMDN Term
- Blood gas analyser IVD, point-of-care FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1120 FDA UDI862.1660 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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Also classified as Blood gas analyser IVD, point-of-care.
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- Clinical Blood Gas Mixture — Oxarc, LLC · Class I
- Scott Medical Products — AIRGAS USA LLC · Class I
- Scott Medical Products — AIRGAS USA LLC · Class I
- Clinical Blood Gas — MIDDLESEX GASES & TECHNOLOGIES, INC. · Class I
- Clinical Blood Gas Mixture — ROBERTS OXYGEN CO., INC. · Class I
- Calibration Gas Mixture — Matheson Tri-Gas, Inc. · Class I
Cleared under the same submission
K151982 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 c8676423-01fa-4cda-bdd0-8c060f51ef08 37 fields · synced Jun 8, 2026