NX19 Oxygenator; left-side outlet port

GUDID 50699753450993

Terumo Cardiovascular Systems Corporation

Extracorporeal membrane oxygenator
Primary Device ID50699753450993
NIH Device Record Key31b56761-697c-4b88-8ecf-7166e66b1a65
Commercial Distribution StatusIn Commercial Distribution
Brand NameNX19 Oxygenator; left-side outlet port
Version Model Number3CX*NX19W
Company DUNS177655466
Company NameTerumo Cardiovascular Systems Corporation
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
GS100699753450998 [Primary]
GS150699753450993 [Package]
Contains: 00699753450998
Package: 4 Piece Case [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTZOxygenator, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-26
Device Publish Date2021-03-18

On-Brand Devices [NX19 Oxygenator; left-side outlet port]

506997534509933CX*NX19W
506997534508943CX*NX19W

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