Identity
- Trade Name
- STAT PROFILE FDA UDI
- Generic Name
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator FDA UDI
- Device Name
- STAT PROFILE pHOx PLUS C CALIBRATOR CARTRIDGE C FDA UDI
- Model / Reference
- PHOX PLUS C FDA UDI
- Description
- STAT PROFILE pHOx PLUS C CALIBRATOR CARTRIDGE C FDA UDI
Identifiers
- Catalog Number
- 41888 FDA UDI
- Primary DI / UDI-DI
- 00385480418881 FDA UDI
- 510(k) Number
- K021713 FDA UDI
- FDA Product Code
- JIX FDA UDI
- GMDN Term
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1150 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
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
Yes
Category: Multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrator
The STAT PROFILE is a highly accurate and reliable multiple blood gas/haemoximetry/electrolyte analyte IVD, calibrated for precise measurement of vital signs in clinical settings. With its robust features and extensive analyte coverage, it's an indispensable tool for healthcare professionals, making it a must-have for any medical device directory.
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Cleared under the same submission
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
- Nova Biomedical Corporation
Sources (1)
- FDA UDI a4f4ad7c-ec01-461d-a29d-dcd396697662 37 fields · synced Jun 23, 2026