Identity
- Trade Name
- Calibration Gas 2 FDA UDI
- Generic Name
- Calibration gas/non-refillable cylinder FDA UDI
- Device Name
- Calibration Gas 2 standard 1 Litre, 10% CO2, balance: N2 FDA UDI
- Model / Reference
- 962-096 FDA UDI
- Description
- Calibration Gas 2 standard 1 Litre, 10% CO2, balance: N2 FDA UDI
Identifiers
- Catalog Number
- 962-096 FDA UDI
- Primary DI / UDI-DI
- 05700699620965 FDA UDI
- FDA Product Code
- KLK FDA UDIDQA FDA UDILKD FDA UDILPP FDA UDI
- GMDN Term
- Calibration gas/non-refillable cylinder FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.2500 FDA UDI870.2700 FDA UDI868.2480 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Calibration Gas 2 by Radiometer Medical ApS — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
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Manufacturer
- Manufacturer
- Radiometer Medical ApS
Sources (1)
- FDA UDI e88df630-9f17-4b1d-a7a0-4a8b776fd13a 37 fields · synced May 30, 2026