Identity
- Trade Name
- Scott Medical Products FDA UDI
- Generic Name
- Calibration gas/non-refillable cylinder FDA UDI
- Device Name
- Description: 2% DESFLURANE, 5% CO2, 50% O2, BAL. N2O; Cylinder: BD; Valve: CGA B-188; For calibration of medical analyzers in accordance with manufacturer's instructions. FDA UDI
- Model / Reference
- Anesthesia Calibration Gas FDA UDI
- Description
- Description: 2% DESFLURANE, 5% CO2, 50% O2, BAL. N2O; Cylinder: BD; Valve: CGA B-188; For calibration of medical analyzers in accordance with manufacturer's instructions. FDA UDI
Identifiers
- Catalog Number
- Z04NS43MBDC002 FDA UDI
- Primary DI / UDI-DI
- 00819601025325 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
Dimensions & Sizes
- Size
- Total Volume — 6 Liter FDA UDIPressure — 90 Pound per Square Inch FDA UDI
Category: Calibration gas/non-refillable cylinder
Scott Medical Products by Airgas Therapeutics — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- MedSource O2 Cylinder — MEDSOURCE INTERNATIONAL LLC · Class I
- Scott Medical Products — AIRGAS USA LLC · 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 |
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Manufacturer
- Manufacturer
- Airgas Therapeutics
Sources (1)
- FDA UDI 4a9a816c-e6af-4434-b65b-1692f6e76ce5 37 fields · synced Jun 8, 2026