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Unimed U543-16(3M)

by Unimed Medical Supplies, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

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 Number06945664859103 UDI-DI Date20 Oct 2021ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Unimed
Generic Name
Pulse oximeter probe, single-use
Model / Reference
U543-16(3M)
Primary DI / UDI-DI
06945664859103
510(k) Number
FDA Product Code
DQA
GMDN Term
Pulse oximeter probe, single-use
Device Class
Class II
Regulation Number
870.2700
GUDID distribution status
In Commercial Distribution

Related devices

Category: Pulse oximeter probe, single-use

Cleared under the same submission (K142832)

Show all (12)

Other devices from Unimed Medical Supplies, Inc.

See all devices from Unimed Medical Supplies, Inc. →

Properties

  • Single Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No