Identity
- Trade Name
- RANGE+ QUALICHECK LEV. 1 S7930 FDA UDI
- Generic Name
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, control FDA UDI
- Device Name
- Range+ QUALICHECK level 1, box of 30 ampoules for calibration verification FDA UDI
- Model / Reference
- 944-151 FDA UDI
- Description
- Range+ QUALICHECK level 1, box of 30 ampoules for calibration verification FDA UDI
Identifiers
- Catalog Number
- 944-151 FDA UDI
- Primary DI / UDI-DI
- 05700699441515 FDA UDI
- FDA Product Code
- JJS FDA UDI
- GMDN Term
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Range+ Qualicheck Lev. 1 S7930 by Radiometer Medical ApS — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple blood gas/haemoximetry/electrolyte analyte IVD, control.
- Meter Trax — Bio-Rad Laboratories · Class I
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION · Class I
- Avox-4 CO-Oximeter Control - L2 — INSTRUMENTATION LABORATORY COMPANY · Class I
- i-STAT — Abbott Point of Care Inc. · Class I
- RAPIDSystems™ AutomaticQC Cartridge — Siemens Healthcare Diagnostics · Class II
- Bi-Level Quality Control Kit — Medica Corp. · Class II
- Stat Profile — NOVA BIOMEDICAL CORPORATION · Class II
- GEM System Evaluator 1 — INSTRUMENTATION LABORATORY COMPANY · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Radiometer Medical ApS
Sources (1)
- FDA UDI 60bc590a-4f84-41a2-aaee-d32c592eb774 36 fields · synced Jun 1, 2026