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Leader 6134753

by Cardinal Health 110, 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 Number00096295146264 UDI-DI Date23 Sep 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  • Withdrawn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
Leader
Generic Name
Pulse oximeter
Model / Ref / Catalog
6134753
Primary DI / UDI-DI
00096295146264
FDA Product Code
PGJ
GMDN Term
Pulse oximeter
Device Class
Class II
Regulation Number
870.2700
GUDID distribution status
In Commercial Distribution

Other devices from Cardinal Health 110, Inc.

See all devices from Cardinal Health 110, Inc. →

Properties

  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (10)

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