Capiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res.

GUDID 50699753450788

Terumo Cardiovascular Systems Corporation

Extracorporeal membrane oxygenator
Primary Device ID50699753450788
NIH Device Record Key483cb5ec-5bc5-4bea-8f2c-2d00ee06d78a
Commercial Distribution StatusIn Commercial Distribution
Brand NameCapiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res.
Version Model Number3CX*FX15RW30C
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
GS100699753450783 [Primary]
GS150699753450788 [Package]
Contains: 00699753450783
Package: 4 Piece Case [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTNReservoir, Blood, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-01-22
Device Publish Date2016-01-20

On-Brand Devices [Capiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res.]

506997534508323CX*FX25RWC
506997534508253CX*FX25REC
506997534508183CX*FX15RE40C
506997534508013CX*FX15RE30C
506997534507953CX*FX15RW40C
506997534507883CX*FX15RW30C

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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