Quantum SuperPAC CP Support U- Low Flow

GUDID 18051160303271

SPECTRUM MEDICAL SRL

Cardiopulmonary bypass system blood tubing set
Primary Device ID18051160303271
NIH Device Record Key261fb5c5-044c-44d9-a3b5-7a490b0e23fb
Commercial Distribution StatusIn Commercial Distribution
Brand NameQuantum SuperPAC CP Support U- Low Flow
Version Model NumberSPW075C-C1U
Company DUNS436188505
Company NameSPECTRUM MEDICAL SRL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kittrue
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS118051160303271 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-01-07
Device Publish Date2025-12-30

Devices Manufactured by SPECTRUM MEDICAL SRL

18051160303264 - Quantum SuperPAC CP Support U - High Flow2026-01-07
18051160303271 - Quantum SuperPAC CP Support U- Low Flow2026-01-07
18051160303271 - Quantum SuperPAC CP Support U- Low Flow2026-01-07
18051160303295 - Quantum SuperPAC Cardioplegia - Master Follower2026-01-07
18051160303301 - Quantum SuperPAC Cardioplegia - Quick System2026-01-07
18051160303318 - Quantum SuperPAC Cardioplegia - Clamp System2026-01-07
18051160302236 - Quantum PureFlow Standard Heat Exchanger Low Flow 3/16 W2025-12-31
18051160302274 - Quantum PureFlow Cardioplegia Heat Exchanger Low Flow 3/16 W2025-12-31
18051160303066 - Quantum SuperPAC CPB - 1/2 Venous2025-09-30

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