Identity
- Trade Name
- STAT PROFILE FDA UDI
- Generic Name
- Blood gas/haemoximetry analyser IVD, point-of-care FDA UDI
- Device Name
- Prime CCS Comp Analyzer FDA UDI
- Model / Reference
- PRIME CCS COMP FDA UDI
- Description
- Prime CCS Comp Analyzer FDA UDI
Identifiers
- Catalog Number
- 52857 FDA UDI
- Primary DI / UDI-DI
- 00385480528573 FDA UDI
- 510(k) Number
- K141907 FDA UDI
- FDA Product Code
- JFP FDA UDIJIX FDA UDIKHP FDA UDICHL FDA UDICGZ FDA UDIGKF FDA UDIJJS FDA UDIJGS FDA UDICEM FDA UDICGA FDA UDI
- GMDN Term
- Blood gas/haemoximetry analyser IVD, point-of-care FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1145 FDA UDI862.1150 FDA UDI862.1450 FDA UDI862.1120 FDA UDI862.1170 FDA UDI864.5600 FDA UDI862.1660 FDA UDI862.1665 FDA UDI862.1600 FDA UDI862.1345 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/haemoximetry analyser IVD, point-of-care
Stat Profile by Nova Biomedical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood gas/haemoximetry analyser IVD, point-of-care.
- RAPIDLab® 1200 Series 1240 — Siemens Healthcare Diagnostics · Class II
- RAPIDPOINT® 340 Sampler Module — Siemens Healthcare Diagnostics · Class II
- RAPIDPoint® 500e Blood Gas System — Siemens Healthcare Diagnostics · Class II
- i-STAT — Abbott Point of Care Inc. · Class II
- RAPIDLab® 1200 Series CO-ox Sample Chamber — Siemens Healthcare Diagnostics · Class II
- TB5 Ref Test/Blank Sensor — Siemens Healthcare Diagnostics · Class II
- RAPIDChem® 700, RAPIDPoint® 340 Trouble shooting kit — Siemens Healthcare Diagnostics · Class II
- Valve Module (unheated) — Siemens Healthcare Diagnostics · Class II
Cleared under the same submission
K141907 also covers:
- NOVA — NOVA BIOMEDICAL CORPORATION
- Nova — 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 778542f0-1cc4-44f8-a722-107aee8fc778 37 fields · synced Jun 6, 2026