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Vive Precision DMD1035WHT

by Vive Health LLC

Vive Precision DMD1035WHT is a Class II device made by Vive Health LLC, cleared under FDA 510(k) K171578 on 30 Nov 2017 and listed in FDA GUDID since 2 Aug 2018 (UDI-DI 00818323023541), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K171578

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00818323023541 UDI-DI Date2 Aug 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK171578 Date30 Nov 2017IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K171578 decided 30 Nov 2017 Active
  • FDA GUDID UDI-DI 00818323023541 listed 2 Aug 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K171578
  2. Listed FDA GUDID 00818323023541

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Vive Precision
Generic name
Intermittent electronic patient thermometer
Model / reference
DMD1035WHT
Primary DI / UDI-DI
00818323023541
510(k) Number
FDA product code
FLL
GMDN term
Intermittent electronic patient thermometer
Device class
Class II
Regulation number
880.2910
GUDID distribution status
In Commercial Distribution

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Properties

  • Over-the-counter
Other properties (14, all answered No)