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Quantum Perfusion Blood Oxygenator VT200-E1

by Spectrum Medical Limited GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number18051160300676 UDI-DIDate21 May 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Generic Name
Extracorporeal membrane oxygenator
Model / Reference
VT200-E1
Primary DI / UDI-DI
18051160300676
510(k) Number
FDA Product Code
DTZ
GMDN Term
Extracorporeal membrane oxygenator
Device Class
Class II
Regulation Number
870.4350
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Cleared under the same submission (K203424)

Other devices from Spectrum Medical Limited

See all devices from Spectrum Medical Limited →

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