CDI™ H/S Cuvette 1/4 x 1/4 with Extension

GUDID 50699753269045

Terumo Cardiovascular Systems Corporation

Cardiopulmonary bypass system blood gas sensor Cardiopulmonary bypass system blood gas sensor
Primary Device ID50699753269045
NIH Device Record Key20b9a4ae-3bcb-4322-8ea1-8cb60864253b
Commercial Distribution StatusIn Commercial Distribution
Brand NameCDI™ H/S Cuvette 1/4 x 1/4 with Extension
Version Model Number6934
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
GS100699753269040 [Primary]
GS130699753269041 [Package]
Contains: 00699753269040
Package: 10 Piece Case [10 Units]
In Commercial Distribution
GS150699753269045 [Package]
Contains: 30699753269041
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

00699753531390 - Cardiovascular Procedure Kit2024-05-20
00699753531406 - Cardiovascular Procedure Kit2024-05-20
00699753531413 - Cardiovascular Procedure Kit2024-05-20
00699753531420 - Cardiovascular Procedure Kit2024-05-20
00699753531338 - Cardiovascular Procedure Kit2024-05-17
00699753531345 - Cardiovascular Procedure Kit2024-05-17
00699753531352 - Cardiovascular Procedure Kit2024-05-17
00699753531369 - Cardiovascular Procedure Kit2024-05-17

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.