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Western/Scott Fetzer

FDA UDI

Class I (US FDA UDI)

by Western Enterprises, Inc.

Identity

Trade Name
Western/Scott Fetzer FDA UDI
Generic Name
Non-fixed medical gas cylinder regulator FDA UDI
Device Name
SHAIR REGULATOR/CGA280/45PSI FDA UDI
Model / Reference
MSH45280 FDA UDI
Description
SHAIR REGULATOR/CGA280/45PSI FDA UDI

Identifiers

Catalog Number
MSH45280 FDA UDI
Primary DI / UDI-DI
B929MSH452800 FDA UDI
FDA Product Code
CAN FDA UDI
GMDN Term
Non-fixed medical gas cylinder regulator FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
868.2700 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

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
MRI Safety
MR Unsafe FDA UDI

Category: Non-fixed medical gas cylinder regulator

Western/Scott Fetzer by Western Enterprises, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Non-fixed medical gas cylinder regulator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Western Enterprises, Inc.

Sources (1)

  • FDA UDI ecb3985d-bfe7-4865-b039-5f4759542e46 35 fields · synced May 31, 2026