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KismeTruth Remote Patient Monitoring 10109

by Remote Smart Health LLC 2 variants

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 Number00850047516039 UDI-DI Date19 Mar 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  • Withdrawn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
KismeTruth Remote Patient Monitoring
Generic Name
Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Model / Reference
10109
Primary DI / UDI-DI
00850047516039
FDA Product Code
DXN
GMDN Term
Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Device Class
Class II
Regulation Number
870.1130
GUDID distribution status
In Commercial Distribution

Other devices from Remote Smart Health LLC

Properties

  • Single Use
  • Over-the-Counter

Other properties (12)

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