Identity
- Trade Name
- Western/Scott Fetzer FDA UDI
- Generic Name
- Fixed medical gas cylinder regulator FDA UDI
- Device Name
- INFINITY 1 KNOB"E"CYL 2015 PSI FDA UDI
- Model / Reference
- MXS-603 FDA UDI
- Description
- INFINITY 1 KNOB"E"CYL 2015 PSI FDA UDI
Identifiers
- Catalog Number
- MXS-603 FDA UDI
- Primary DI / UDI-DI
- B929MXS6030 FDA UDI
- FDA Product Code
- CAN FDA UDI
- GMDN Term
- Fixed medical gas cylinder regulator FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.2700 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Western/Scott Fetzer by Western Enterprises, Inc. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Western Enterprises, Inc.
Sources (1)
- FDA UDI e1cfbf42-0d61-4faa-b28d-2655a2e3d5f0 36 fields · synced May 30, 2026