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Fl-10000U Fl-10000-02U

by Flexicare Medical Limited

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05055931109204 UDI-DI Date19 Jun 2026ListedStatusListed 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  • Withdrawn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
Fl-10000U
Generic Name
Heated respiratory humidifier
Model / Reference
FL-10000-02U
Primary DI / UDI-DI
05055931109204
FDA Product Code
BTT
GMDN Term
Heated respiratory humidifier
Device Class
Class II
Regulation Number
868.5450
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Other devices from Flexicare Medical Limited

See all devices from Flexicare Medical Limited →

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

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
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No