Quantum SuperPAC CPB – 3/8 Venous with AV Bridge

GUDID 18051160303196

SPECTRUM MEDICAL SRL

Cardiopulmonary bypass system blood tubing set
Primary Device ID18051160303196
NIH Device Record Key4a80d199-73bb-40c2-92e9-1365f6ed75e6
Commercial Distribution StatusIn Commercial Distribution
Brand NameQuantum SuperPAC CPB – 3/8 Venous with AV Bridge
Version Model NumberSPC200A-D4
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
GS118051160303196 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-30
Device Publish Date2025-09-22

On-Brand Devices [Quantum SuperPAC CPB – 3/8 Venous with AV Bridge]

18051160303196SPC200A-D4
18051160303325SPC160A-D4

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