Capiox® Hardshell Reservoir

GUDID 50699753450160

Terumo Cardiovascular Systems Corporation

Cardiotomy reservoir
Primary Device ID50699753450160
NIH Device Record Keyb1575053-c761-40cc-9876-f6b078f66a59
Commercial Distribution Discontinuation2018-12-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NameCapiox® Hardshell Reservoir
Version Model NumberCX*SXRX
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
GS100699753450165 [Primary]
GS150699753450160 [Package]
Contains: 00699753450165
Package: 4 Piece Case [4 Units]
Discontinued: 2018-12-01
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTZOxygenator, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-01-22
Device Publish Date2015-10-02

On-Brand Devices [Capiox® Hardshell Reservoir]

50699753450399CX*CRXA
50699753450160CX*SXRX

Trademark Results [Capiox]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CAPIOX
CAPIOX
74561748 1957236 Live/Registered
TERUMO KABUSHIKI KAISHA
1994-08-16
CAPIOX
CAPIOX
73401694 1295899 Dead/Cancelled
Terumo Kabushiki Kaisha
1982-11-04

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