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Trulink NIBP Hoses and adapters

by Spacelabs Healthcare (Washington), Inc 29 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

2 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10841522126413 UDI-DI Date16 Jul 2024ListedStatusListed GUDID: in commercial distribution

Recalls

2 recalls · FDA

    • Terminated Z-2573-2011 FDA Unclassified (pre-2012) initiated 12 May 2011 on shared 510(k) K031124

    Capnography Module, Model 91517, resets 20 seconds after power failure, instead of after three minutes as specified. This reset clears the RAM and the module returns to default settings.

    • Terminated Z-0517-06 FDA Unclassified (pre-2012) initiated 20 Jul 2005

    The transducer used to compensate for pressure changes was mounted backwards on the printed circuit board assembly. The module will not compensate for pressure changes and CO2 readings will be inaccurate at higher altitudes.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Trulink
Generic Name
Gas-sampling/monitoring respiratory tubing, single-use
Model / Ref / Catalog
NIBP Hoses and adapters, 704-0027
Primary DI / UDI-DI
10841522126413
510(k) Number
FDA Product Code
CCK
GMDN Term
Gas-sampling/monitoring respiratory tubing, single-use
Device Class
Class II
Regulation Number
868.1400
GUDID distribution status
In Commercial Distribution

Related devices

Category: Gas-sampling/monitoring respiratory tubing, single-use

Cleared under the same submission (K031124)

Show all (12)

Other devices from Spacelabs Healthcare (Washington), Inc

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

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No