Skip to content

Spacelabs Healthcare SUPPLY

by Spacelabs Healthcare (Washington), Inc 16 variants

Listed FDA GUDID listing, not in commercial distribution

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 Number10841522101403 UDI-DI Date21 Nov 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

2 recalls · FDA

    • Terminated Z-2586-2014 FDA Class II initiated 2 Jul 2014

    The transmitter display and the Telemetry Central Station display may show a SpO2 value when the sensor is not connected to the patient or in certain sensor failed conditions. This is an expansion of recall Z-0871-2014 because additional serial numbers were identified as being part of this recall action as part of the firm's retrospective analysis of all recalls since 2011.

    • Terminated Z-0871-2014 FDA Class II initiated 19 Dec 2013

    The AriaTele Model 96281 with SpO2 monitoring Option C is recalled because the AriaTele (transmitter) display and the Telemetry Central Station display may show a SpO2 value when the sensor is not connected to the patient or in certain sensor failed conditions.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Spacelabs Healthcare
Generic Name
Electrocardiographic lead set, reusable
Model / Ref / Catalog
SUPPLY
Primary DI / UDI-DI
10841522101403
510(k) Number
FDA Product Code
MHX
GMDN Term
Electrocardiographic lead set, reusable
Device Class
Class II
Regulation Number
870.1025
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K121480)

Other devices from Spacelabs Healthcare (Washington), Inc

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

Properties

  • Lot / Batch Number

Other properties (13)

  • 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
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No