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Quantum Perfusion Dual Lumen Cannula 31F DL31F-V0

by Spectrum Medical Limited 2 variants

Listed FDA GUDID listing, no authorization on record

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 Number18051160300799 UDI-DI Date21 May 2026ListedStatusListed GUDID: 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  • Withdrawn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
Quantum Perfusion Dual Lumen Cannula 31F
Generic Name
Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
Model / Reference
DL31F-V0
Primary DI / UDI-DI
18051160300799
510(k) Number
FDA Product Code
DWF
GMDN Term
Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
Device Class
Class II
Regulation Number
870.4210
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Cleared under the same submission (K203067)

Cleared under the same submission (K221353)

Show all (12)

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

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