CAPIOX®FX

GUDID 04987350701084

FX25

TERUMO CORPORATION

Extracorporeal membrane oxygenator
Primary Device ID04987350701084
NIH Device Record Keyadcafc6e-b20b-47f0-b61b-c59460a92903
Commercial Distribution StatusIn Commercial Distribution
Brand NameCAPIOX®FX
Version Model NumberCX*FX25W
Company DUNS690543319
Company NameTERUMO 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

Customer Support Contacts

Phone1-800-521-2818
Emailcvscustomerservice@terumomedical.com

Device Dimensions

Area/Surface Area2.5 Square meter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Fragile. This way up. Keep away from sunlight. Keep away from rain.
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile. This way up. Keep away from sunlight. Keep away from rain.

Device Identifiers

Device Issuing AgencyDevice ID
GS104987350701084 [Primary]

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 Number3
Public Version Date2020-01-22
Device Publish Date2015-09-15

On-Brand Devices [CAPIOX®FX]

04987350781772FX05
04987350781758FX05
04987350781734FX05
04987350781710FX05
04987350701206FX15
04987350701183FX15
04987350701169FX15
04987350701145FX15
04987350701121FX15
04987350701107FX15
04987350701084FX25
04987350701060FX25
04987350701046FX25
04987350701022FX25

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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