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OMBRA* Table Top Compressor System 105510

by Trudell Medical International

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 Number00762860000582 UDI-DIDate6 Nov 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  • Withdrawn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
OMBRA* Table Top Compressor System
Generic Name
Medical device air compressor
Model / Ref / Catalog
105510, 10551094006
Primary DI / UDI-DI
00762860000582
510(k) Number
FDA Product Code
BTI
GMDN Term
Medical device air compressor
Device Class
Class II
Regulation Number
868.6250
GUDID distribution status
In Commercial Distribution

Other devices from Trudell Medical International

See all devices from Trudell Medical International →

Properties

  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Serial Number

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No
  • Manufacturing Date: No