CSC 14

GUDID 38033178109063

SORIN GROUP ITALIA SRL

Cardiopulmonary bypass system heat exchanger, reusable
Primary Device ID38033178109063
NIH Device Record Keyd8691b33-45cb-4ca5-80d9-d1c0e2ddc6b4
Commercial Distribution StatusIn Commercial Distribution
Brand NameCSC 14
Version Model NumberCSC14 + PURGE LINE
Company DUNS442126587
Company NameSORIN GROUP ITALIA SRL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108033178109062 [Primary]
GS138033178109063 [Package]
Contains: 08033178109062
Package: BOX [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTRHEAT-EXCHANGER, CARDIOPULMONARY BYPASS

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-11
Device Publish Date2015-07-10

Devices Manufactured by SORIN GROUP ITALIA SRL

38033178018648 - Suction tip2024-04-12
38033178018655 - Suction tip2024-04-12
38033178018662 - Suction tip2024-04-12
38033178018679 - Suction tip2024-04-12
38033178018709 - Suction tip2024-04-12
38033178018716 - Suction tip2024-04-12
38033178018723 - Suction tip2024-04-12
38033178018730 - Suction tip2024-04-12

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