Overpressure Safety Valve - Japan

GUDID 50699753450238

Terumo Cardiovascular Systems Corporation

Cardiopulmonary bypass system valve, unidirectional flow/pressure control
Primary Device ID50699753450238
NIH Device Record Key742e95aa-83a0-4cee-8699-b3b1482eeae7
Commercial Distribution StatusIn Commercial Distribution
Brand NameOverpressure Safety Valve - Japan
Version Model NumberLH130J
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
GS100699753450233 [Primary]
GS130699753450234 [Package]
Contains: 00699753450233
Package: 5 Piece Case [5 Units]
In Commercial Distribution
GS150699753450238 [Package]
Contains: 30699753450234
Package: 5 Piece Case [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-06

Devices Manufactured by Terumo Cardiovascular Systems Corporation

00699753533417 - Cardiovascular Procedure Kit2024-11-19
00699753533400 - Cardiovascular Procedure Kit2024-11-15
00699753533363 - Cardiovascular Procedure Kit2024-11-12
50699753533375 - Cardiovascular Procedure Kit2024-11-12
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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