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TRULINK NIBP Hoses and adapters

by Spacelabs Healthcare (Washington), Inc 29 variants

TRULINK NIBP Hoses and adapters (650-0362-00) is a Class II device made by Spacelabs Healthcare (Washington), Inc, cleared under FDA 510(k) K954282 on 6 Feb 1996 and listed in FDA GUDID since 14 Mar 2017 (UDI-DI 10841522101083), 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) K954282

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 Number10841522101083 UDI-DI Date14 Mar 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK954282 Date6 Feb 1996DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K954282 decided 6 Feb 1996 Active
  • FDA GUDID UDI-DI 10841522101083 listed 14 Mar 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K954282
  2. Listed FDA GUDID 10841522101083

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Trulink
Generic name
Blood pressure cuff, reusable
Model / Ref / Catalog
NIBP Hoses and adapters, 650-0362-00
Primary DI / UDI-DI
10841522101083
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

Similar devices

Other devices filed under FDA product code DXQ (blood pressure cuff).

Other devices from Spacelabs Healthcare (Washington), Inc

See all devices from Spacelabs Healthcare (Washington), Inc →

Properties

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