NX19 Oxygenator w/4-liter reservoir; right-side outlet port

GUDID 50699753450863

Terumo Cardiovascular Systems Corporation

Extracorporeal membrane oxygenator
Primary Device ID50699753450863
NIH Device Record Key75b705bd-afb4-4680-ace0-62d6446373b3
Commercial Distribution StatusIn Commercial Distribution
Brand NameNX19 Oxygenator w/4-liter reservoir; right-side outlet port
Version Model Number3CX*NX19RE
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
GS100699753450868 [Primary]
GS150699753450863 [Package]
Contains: 00699753450868
Package: 4 Piece Case [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTNReservoir, Blood, 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

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50699753533382 - Cardiovascular Procedure Kit2024-11-12
00699753533394 - Cardiovascular Procedure Kit2024-11-12
50699753533306 - Cardiovascular Procedure Kit2024-11-11
00699753533318 - Cardiovascular Procedure Kit2024-11-11

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