CDI™ H/S Cuvette 1/2 x 1/2

GUDID 50699753270140

Terumo Cardiovascular Systems Corporation

Cardiopulmonary bypass system blood gas sensor Cardiopulmonary bypass system blood gas sensor
Primary Device ID50699753270140
NIH Device Record Keyd7cf3ba8-f72f-47a9-9ce1-ce5d3e591713
Commercial Distribution StatusIn Commercial Distribution
Brand NameCDI™ H/S Cuvette 1/2 x 1/2
Version Model Number6912
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 Batchfalse
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
GS100699753270145 [Primary]
GS130699753270146 [Package]
Contains: 00699753270145
Package: 20 Piece Case [20 Units]
In Commercial Distribution
GS150699753270140 [Package]
Contains: 30699753270146
Package: 6 Piece Case [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DRYMonitor, Blood-Gas, On-Line, 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

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00699753531192 - Cardiovascular Procedure Kit2024-04-18
00699753531208 - Cardiovascular Procedure Kit2024-04-18
50699753531104 - Cardiovascular Procedure Kit2024-04-15
50699753531111 - Cardiovascular Procedure Kit2024-04-15

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