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Transcend WhisperSoft 4

by Somnetics International, Inc 2 variants

Transcend WhisperSoft 4 (503121) is a Class I device made by Somnetics International, Inc, listed in FDA GUDID since 3 Aug 2022 (UDI-DI M950503121), registry data as of 23 Oct 2026.

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberM950503121 UDI-DI Date3 Aug 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  • Withdrawn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
Transcend
Generic name
Inspiratory/expiratory limb respiratory tubing, single-use
Model / Ref / Catalog
WhisperSoft 4, 503121
Primary DI / UDI-DI
M950503121
FDA product code
BYX
GMDN term
Inspiratory/expiratory limb respiratory tubing, single-use
Device class
Class I
Regulation number
868.5860
GUDID distribution status
In Commercial Distribution

Related devices

Category: Inspiratory/expiratory limb respiratory tubing, single-use

Other devices from Somnetics International, Inc

See all devices from Somnetics International, Inc →

Properties

  • Premarket exempt
  • Lot / batch number
Other properties (13, all answered No)