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Perfusion Pack

by LivaNova USA, Inc. 84 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 2 Nov 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 2 Nov 2026. What this means

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00803622164941 UDI-DI Date19 Oct 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 2 Nov 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Cardiopulmonary bypass system blood tubing set
Model / Reference
Perfusion Pack
Primary DI / UDI-DI
00803622164941
510(k) Number
FDA Product Code
DWE
GMDN Term
Cardiopulmonary bypass system blood tubing set
Device Class
Class II
Regulation Number
870.4390
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K233702)

Show all (12)

Other devices from LivaNova USA, Inc.

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

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