CDI™ H/S Cuvette 1/2 x 1/2 with Extension

GUDID 50699753269021

Terumo Cardiovascular Systems Corporation

Cardiopulmonary bypass system blood gas sensor Cardiopulmonary bypass system blood gas sensor
Primary Device ID50699753269021
NIH Device Record Key665a514f-677d-4fbd-8a20-e19cf90c39cc
Commercial Distribution StatusIn Commercial Distribution
Brand NameCDI™ H/S Cuvette 1/2 x 1/2 with Extension
Version Model Number6932
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
GS100699753269026 [Primary]
GS130699753269027 [Package]
Contains: 00699753269026
Package: 10 Piece case [10 Units]
In Commercial Distribution
GS150699753269021 [Package]
Contains: 30699753269027
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

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