Quantum SuperPAC Hybrid CPB

GUDID 18051160303332

SPECTRUM MEDICAL SRL

Cardiopulmonary bypass system blood tubing set
Primary Device ID18051160303332
NIH Device Record Key3ac1069b-5200-401f-b037-15a3d5ea65c1
Commercial Distribution StatusIn Commercial Distribution
Brand NameQuantum SuperPAC Hybrid CPB
Version Model NumberSPC160A-D5
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
GS118051160303332 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-09
Device Publish Date2026-01-30

On-Brand Devices [Quantum SuperPAC Hybrid CPB]

18051160303202SPC200A-D5
18051160303332SPC160A-D5

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