CAPIOX®RX

GUDID 04987350769534

RX25

TERUMO CORPORATION

Extracorporeal membrane oxygenator
Primary Device ID04987350769534
NIH Device Record Key5358f353-0d95-41f4-83b8-715aa423bb92
Commercial Distribution StatusIn Commercial Distribution
Brand NameCAPIOX®RX
Version Model NumberCX*RX25W
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
GS104987350769534 [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®RX]

54987350781852RX05
04987350771216RX15
04987350771193RX15
04987350771094RX15
04987350771070RX15
04987350771056RX15
04987350771032RX15
04987350769572RX25
04987350769558RX25
04987350769534RX25
04987350769510RX25
04987350763495RX05
04987350763471RX05

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

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