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Smartheart 11-51DA

by Veridian Healthcare LLC

Smartheart 11-51DA is a Class II device made by Veridian Healthcare LLC, listed in FDA GUDID since 29 Sep 2026 (UDI-DI 00845717013765), registry data as of 23 Oct 2026.

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00845717013765 UDI-DI Date29 Sep 2026ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Smartheart
Generic name
Pulse oximeter
Model / reference
11-51DA
Primary DI / UDI-DI
00845717013765
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 Veridian Healthcare

See all devices from Veridian Healthcare →

Properties

  • Over-the-counter
  • Premarket exempt
  • Lot / batch number
Other properties (12, all answered No)