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GatewayMD SmartBP LS802-GP

by Gatewaymd, LLC

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 Number00860009529007 UDI-DI Date14 Dec 2022ListedStatusListed 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  • Withdrawn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
GatewayMD SmartBP
Generic Name
Blood pressure cuff, reusable
Model / Reference
LS802-GP
Primary DI / UDI-DI
00860009529007
FDA Product Code
DXN
GMDN Term
Blood pressure cuff, reusable
Device Class
Class II
Regulation Number
870.1130
GUDID distribution status
In Commercial Distribution

Related devices

Category: Blood pressure cuff, reusable

Properties

  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: 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
  • Expiration Date: No