Identity
- Trade Name
- Scott Medical Products FDA UDI
- Generic Name
- Blood gas analyser IVD, point-of-care FDA UDI
- Device Name
- Description: 8% DESFLURANE, BAL. N2; Cylinder: XL; Valve: CGA 510; For calibration of medical analyzers in accordance with manufacturer's instructions. FDA UDI
- Model / Reference
- Calibration Gas FDA UDI
- Description
- Description: 8% DESFLURANE, BAL. N2; Cylinder: XL; Valve: CGA 510; For calibration of medical analyzers in accordance with manufacturer's instructions. FDA UDI
Identifiers
- Catalog Number
- Z02NI92M350Y195 FDA UDI
- Primary DI / UDI-DI
- 00819601020436 FDA UDI
- FDA Product Code
- BXK FDA UDI
- GMDN Term
- Blood gas analyser IVD, point-of-care 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 — 384 Liter FDA UDIPressure — 52 Pound per Square Inch FDA UDI
Category: Blood gas analyser IVD, point-of-care
Scott Medical Products by Airgas Usa Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood gas analyser IVD, point-of-care.
- Calibration Mixture — RED BALL OXYGEN COMPANY · Class I
- Clinical Blood Gas Mixture — A-OX WELDING SUPPLY CO., INC. · Class I
- Clinical Blood Gas Mixture — Oxarc, LLC · Class I
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION · Class II
- Clinical Blood Gas — MIDDLESEX GASES & TECHNOLOGIES, INC. · Class I
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION · Class II
- Clinical Blood Gas Mixture — ROBERTS OXYGEN CO., INC. · Class I
- Calibration Gas Mixture — Matheson Tri-Gas, Inc. · 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
- Airgas Usa Llc
Sources (1)
- FDA UDI d33c3b40-1610-471f-b0bf-e05877f227d2 37 fields · synced May 30, 2026