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Quantum PureFlow KIT CPC - Barbed Connector Adaptor CONN-HX1

by Spectrum Medical Limited 2 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number28051160301564 UDI-DI Date21 May 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Quantum PureFlow KIT CPC - Barbed Connector Adaptor
Generic Name
Cardiopulmonary bypass system heat exchanger, reusable
Model / Reference
CONN-HX1
Primary DI / UDI-DI
28051160301564
FDA Product Code
KRI
GMDN Term
Cardiopulmonary bypass system heat exchanger, reusable
Device Class
Class I
Regulation Number
870.4200
GUDID distribution status
In Commercial Distribution

Other devices from Spectrum Medical Limited

See all devices from Spectrum Medical Limited →

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

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