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ViaMed 13450-BLACK

by Rece International Corp.

ViaMed 13450-BLACK is a Class II device made by Rece International Corp., cleared under FDA 510(k) K043286 on 13 Jan 2005 and listed in FDA GUDID since 27 Nov 2020 (UDI-DI 00811382010804), active as of 22 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 22 Oct 2026

Documents

510(k) K043286

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00811382010804 UDI-DI Date27 Nov 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK043286 Date13 Jan 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K043286 decided 13 Jan 2005 Active
  • FDA GUDID UDI-DI 00811382010804 listed 27 Nov 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K043286
  2. Listed FDA GUDID 00811382010804

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ViaMed
Generic name
Blood pressure cuff, reusable
Model / reference
13450-BLACK
Primary DI / UDI-DI
00811382010804
510(k) Number
FDA product code
DXQ
GMDN term
Blood pressure cuff, reusable
Device class
Class II
Regulation number
870.1120
GUDID distribution status
In Commercial Distribution

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Properties

  • Contains latex
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)