Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2

GUDID 18051160301796

SPECTRUM MEDICAL SRL

Extracorporeal membrane oxygenator
Primary Device ID18051160301796
NIH Device Record Key55c3958c-27e2-4e06-82a0-0bbc87042c67
Commercial Distribution StatusIn Commercial Distribution
Brand NameQuantum Perfusion Blood Oxygenator with Integrated AF VT75-C2
Version Model NumberVT75-C2
Company DUNS436188505
Company NameSPECTRUM MEDICAL SRL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS118051160301796 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTZOxygenator, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-19
Device Publish Date2025-09-11

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