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Device HOLDER WITH MAST-CLAMP LONG

by LivaNova Deutschland GmbH

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

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 Number04033817904137 UDI-DI Date22 Jan 2026ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0571-2025 FDA Class II initiated 18 Oct 2024

    Heart-Lung Machine GUI touchscreen may go dark for 10-15 seconds, safety/performance functions remain operational before reset, control maintained through backup control panel, but second reset may occur, may lead to gas blender standby, then gas blender must be reactivated using user interface on blender, sensors deactivated until new case started; GUI reset can lead to Hypoxia and Hypoperfusion.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Device
Generic Name
Cardiopulmonary bypass system, roller type
Model / Reference
HOLDER WITH MAST-CLAMP LONG
Primary DI / UDI-DI
04033817904137
510(k) Number
FDA Product Code
DTQ
GMDN Term
Cardiopulmonary bypass system, roller type
Device Class
Class II
Regulation Number
870.4220
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K232291)

Show all (12)

Other devices from LivaNova Deutschland GmbH

See all devices from LivaNova Deutschland GmbH →

Properties

  • Prescription Use
  • Manufacturing Date

Other properties (12)

  • 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
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No