Venous Cardiopolmunary Bypass Cannula

GUDID 38033178018617

SORIN GROUP ITALIA SRL

Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
Primary Device ID38033178018617
NIH Device Record Key7834fdfa-12b4-46c5-a385-6bc76dc1c504
Commercial Distribution StatusIn Commercial Distribution
Brand NameVenous Cardiopolmunary Bypass Cannula
Version Model NumberRV-41036
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
GS108033178018616 [Primary]
GS138033178018617 [Package]
Contains: 08033178018616
Package: CASE [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWFCatheter, cannula and tubing, vascular, cardiopulmonary bypass

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-29
Device Publish Date2025-12-19

On-Brand Devices [Venous Cardiopolmunary Bypass Cannula]

38033178018617RV-41036
38033178018600RV-41034
38033178018594RV-41032
38033178018587RV-41030
38033178018570RV-41028
38033178018563RV-41026
38033178018556RV-41024
38033178018549RV-41022
38033178018532RV-41020
38033178018525RV-41018
38033178018488RV-40536
38033178018464RV-40036
38033178018457RV-40034
38033178018440RV-40032
38033178018433RV-40030
38033178018426RV-40028
38033178018419RV-40026
38033178018402RV-40024
38033178018396RV-40022
38033178018389RV-40020
38033178018372RV-40018
38033178018365RV-40016
38033178018334RTS-13129
38033178018327RTS-13029
38033178018310RTS-11129
38033178018303RTS-11029
38033178018297RDS-61150
38033178018280RDS-61146
38033178018273RDS-61140
38033178018266RDS-61137
38033178018259RDS-61134
38033178018235RDS-61046
38033178018228RDS-61040
38033178018211RDS-61037
38033178018204RDS-61034

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