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Spacelabs Healthcare TAY; ARIA

by Spacelabs Healthcare (Washington), Inc 3 variants

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number10841522118449 UDI-DI Date19 Apr 2017ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

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  • Withdrawn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
TAY, ARIA, 700-0368-00
Primary DI / UDI-DI
10841522118449
510(k) Number
FDA Product Code
DQK
GMDN Term
Electrocardiographic lead set, reusable
Models / Variants
Device Class
Class II
Regulation Number
870.1425
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K050225)

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 (11)

  • Sterile: No
  • Single Use: 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