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Western/Scott Fetzer FM604

by Western Enterprises, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB929FM6040 UDI-DI Date10 Jun 2022ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Western/Scott Fetzer
Generic name
Medical gas flowmeter, Thorpe tube
Model / Ref / Catalog
FM604
Primary DI / UDI-DI
B929FM6040
FDA product code
CAX
GMDN term
Medical gas flowmeter, Thorpe tube
Device class
Class I
Regulation number
868.2340
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Medical gas flowmeter, Thorpe tube

Other devices from Western Enterprises, Inc.

See all devices from Western Enterprises, Inc. →

Properties

  • Prescription use
  • Premarket exempt

Other properties (13)

  • Supplied sterile: No
  • Sterilise before use: No
  • Single use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Lot / batch number: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No