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DreamStation

by Respironics Inc. 21 variants

Listed FDA GUDID listing, not in commercial distribution

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 Number00606959048997 UDI-DI Date20 Dec 2017ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Medical networking interface unit
Model / Ref / Catalog
DreamStation Wi-Fi Accessory with Oximetry, AU, 100740W
Primary DI / UDI-DI
00606959048997
FDA Product Code
OUG
GMDN Term
Medical networking interface unit
Device Class
Class I
Regulation Number
880.6310
GUDID distribution status
Not in Commercial Distribution

Other devices from Respironics Inc.

See all devices from Respironics Inc. →

Properties

  • Prescription Use
  • Premarket Exempt
  • Serial Number

Other properties (11)

  • Sterile: 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
  • Expiration Date: No
  • Manufacturing Date: No