Arterial Cannula

GUDID 38033178001091

SORIN GROUP ITALIA SRL

Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial
Primary Device ID38033178001091
NIH Device Record Key226ffe81-f2e8-4cb5-be81-86f8432fb868
Commercial Distribution StatusIn Commercial Distribution
Brand NameArterial Cannula
Version Model NumberA211-30N
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
GS108033178001090 [Primary]
GS138033178001091 [Package]
Contains: 08033178001090
Package: BOX [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQRCANNULA, CATHETER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-08-05
Device Publish Date2016-03-21

On-Brand Devices [Arterial Cannula]

38033178011991A281-80B
38033178011861A282-80B
38033178011496A291-80B
38033178011472A281-80A
38033178011458A282-80A
38033178011427A292-80C
38033178011410A291-80C
38033178008540A212-73A
38033178008526A212-73B
38033178008489A212-73C
38033178005556A292-80B
38033178005549A292-70C
38033178005440A281-70C
38033178005204A291-70C
38033178005181A291-70B
38033178005075A282-80C
38033178004986A282-70C
38033178004979A282-70B
38033178004962A282-70A
38033178004856A292-70B
38033178004788A281-70B
38033178003897A281-80C
38033178003316A262-80C
38033178003309A262-65C
38033178003170A262-80B
38033178003163A262-65B
38033178003026A262-65A
38033178002470A232-80C
38033178002463A232-65C
38033178002456A232-52C
38033178002449A232-45C
38033178002432A232-38C
38033178002425A232-30C
38033178002333A232-80B
38033178002326A232-65B
38033178002319A232-52B
38033178002302A232-45B
38033178002296A232-38B
38033178002289A232-30B
38033178002180A232-65A
38033178001633A222-80C
38033178001626A222-65C
38033178001619A222-52C
38033178001602A222-45C
38033178001596A222-38C
38033178001589A222-30C
38033178001534A221-45C
38033178001527A221-38C
38033178001510A221-30C
38033178001497A222-80B

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