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Resp-O2 Universal Cuff Adaptor, Standard 22 mm ID Connections 34511

by Dynarex Corp.

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 Number00840117340282 UDI-DI Date30 Sep 2025ListedStatusListed 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  • Withdrawn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
Resp-O2 Universal Cuff Adaptor, Standard 22 mm ID Connections
Generic Name
Therapeutic agent nebulizer, benchtop
Model / Reference
34511
Primary DI / UDI-DI
00840117340282
FDA Product Code
BYX
GMDN Term
Therapeutic agent nebulizer, benchtop
Device Class
Class I
Regulation Number
868.5860
GUDID distribution status
In Commercial Distribution

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Properties

  • Premarket Exempt
  • Lot / Batch Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No