Identity
- Trade Name
- DIAMOND DIAGNOSTICS FDA UDI
- Generic Name
- Calibration gas/non-refillable cylinder FDA UDI
- Device Name
- Calibration Gas Kit; Containing: 1 - SM-105070D-2 (00819601025776); 1- SM-105070D-1 (00819601025769); For calibration of medical analyzers in accordance with manufacturer's instructions. FDA UDI
- Model / Reference
- Calibration Gas FDA UDI
- Description
- Calibration Gas Kit; Containing: 1 - SM-105070D-2 (00819601025776); 1- SM-105070D-1 (00819601025769); For calibration of medical analyzers in accordance with manufacturer's instructions. FDA UDI
Identifiers
- Catalog Number
- KSMT46837DS2QD FDA UDI
- Primary DI / UDI-DI
- 00819601025783 FDA UDI
- FDA Product Code
- BXK FDA UDI
- GMDN Term
- Calibration gas/non-refillable cylinder FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.6400 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
No
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: Calibration gas/non-refillable cylinder
Diamond Diagnostics by Airgas Therapeutics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Airgas Therapeutics
Sources (1)
- FDA UDI 12ea224d-8e2b-4eec-ae55-8484e24da287 36 fields · synced May 31, 2026