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Carefine IPN-31-08

by Promisemed Medical Devices Inc.

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 Number00850011833094 UDI-DI Date20 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  • Withdrawn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
Carefine
Generic Name
Autoinjector needle
Model / Reference
IPN-31-08
Primary DI / UDI-DI
00850011833094
FDA Product Code
FMI
GMDN Term
Autoinjector needle
Device Class
Class II
Regulation Number
880.5570
GUDID distribution status
In Commercial Distribution

Other devices from Promisemed Medical Devices Inc.

See all devices from Promisemed Medical Devices Inc. →

Properties

  • Sterile
  • Single Use
  • Over-the-Counter
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No