Sinergy and Mini Bag CPB

GUDID 08033178101547

SORIN GROUP ITALIA SRL

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Primary Device ID08033178101547
NIH Device Record Key828b0445-5176-44b2-bfae-a44d5edbe79a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSinergy and Mini Bag CPB
Version Model NumberHolder
Company DUNS442126587
Company NameSORIN GROUP ITALIA SRL
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108033178101547 [Primary]

FDA Product Code

KRIACCESSORY EQUIPMENT, CARDIOPULMONARY BYPASS

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-01
Device Publish Date2023-10-24

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