CAPIOX ZZ*CP50A

GUDID 54987350743256

CAPIOX CARDIOPLEGIA

TERUMO CORPORATION

Cardiopulmonary bypass system heat exchanger, single-use
Primary Device ID54987350743256
NIH Device Record Key0c71ad0f-1c20-46d3-ae0e-ec7f2f237466
Commercial Distribution StatusIn Commercial Distribution
Brand NameCAPIOX
Version Model NumberZZ*CP50A
Catalog NumberZZ*CP50A
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

Phone+1(800)521-2818
Emailcvscustomerservice@terumomedical.com
Phone+1(800)521-2818
Emailcvscustomerservice@terumomedical.com
Phone+1(800)521-2818
Emailcvscustomerservice@terumomedical.com
Phone+1(800)521-2818
Emailcvscustomerservice@terumomedical.com
Phone+1(800)521-2818
Emailcvscustomerservice@terumomedical.com
Phone+1(800)521-2818
Emailcvscustomerservice@terumomedical.com
Phone+1(800)521-2818
Emailcvscustomerservice@terumomedical.com
Phone+1(800)521-2818
Emailcvscustomerservice@terumomedical.com
Phone+1(800)521-2818
Emailcvscustomerservice@terumomedical.com
Phone+1(800)521-2818
Emailcvscustomerservice@terumomedical.com
Phone+1(800)521-2818
Emailcvscustomerservice@terumomedical.com
Phone+1(800)521-2818
Emailcvscustomerservice@terumomedical.com
Phone+1(800)521-2818
Emailcvscustomerservice@terumomedical.com
Phone+1(800)521-2818
Emailcvscustomerservice@terumomedical.com
Phone+1(800)521-2818
Emailcvscustomerservice@terumomedical.com
Phone+1(800)521-2818
Emailcvscustomerservice@terumomedical.com
Phone+1(800)521-2818
Emailcvscustomerservice@terumomedical.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT STORE AT EXTREME TEMPERATURES AND HUMIDITY.
Special Storage Condition, SpecifyBetween 0 and 0 *AVOID DIRECT SUNLIGHT.
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT STORE AT EXTREME TEMPERATURES AND HUMIDITY.
Special Storage Condition, SpecifyBetween 0 and 0 *AVOID DIRECT SUNLIGHT.
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT STORE AT EXTREME TEMPERATURES AND HUMIDITY.
Special Storage Condition, SpecifyBetween 0 and 0 *AVOID DIRECT SUNLIGHT.
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT STORE AT EXTREME TEMPERATURES AND HUMIDITY.
Special Storage Condition, SpecifyBetween 0 and 0 *AVOID DIRECT SUNLIGHT.
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT STORE AT EXTREME TEMPERATURES AND HUMIDITY.
Special Storage Condition, SpecifyBetween 0 and 0 *AVOID DIRECT SUNLIGHT.
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT STORE AT EXTREME TEMPERATURES AND HUMIDITY.
Special Storage Condition, SpecifyBetween 0 and 0 *AVOID DIRECT SUNLIGHT.
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT STORE AT EXTREME TEMPERATURES AND HUMIDITY.
Special Storage Condition, SpecifyBetween 0 and 0 *AVOID DIRECT SUNLIGHT.
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT STORE AT EXTREME TEMPERATURES AND HUMIDITY.
Special Storage Condition, SpecifyBetween 0 and 0 *AVOID DIRECT SUNLIGHT.
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT STORE AT EXTREME TEMPERATURES AND HUMIDITY.
Special Storage Condition, SpecifyBetween 0 and 0 *AVOID DIRECT SUNLIGHT.
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT STORE AT EXTREME TEMPERATURES AND HUMIDITY.
Special Storage Condition, SpecifyBetween 0 and 0 *AVOID DIRECT SUNLIGHT.
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT STORE AT EXTREME TEMPERATURES AND HUMIDITY.
Special Storage Condition, SpecifyBetween 0 and 0 *AVOID DIRECT SUNLIGHT.
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT STORE AT EXTREME TEMPERATURES AND HUMIDITY.
Special Storage Condition, SpecifyBetween 0 and 0 *AVOID DIRECT SUNLIGHT.
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT STORE AT EXTREME TEMPERATURES AND HUMIDITY.
Special Storage Condition, SpecifyBetween 0 and 0 *AVOID DIRECT SUNLIGHT.
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT STORE AT EXTREME TEMPERATURES AND HUMIDITY.
Special Storage Condition, SpecifyBetween 0 and 0 *AVOID DIRECT SUNLIGHT.
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT STORE AT EXTREME TEMPERATURES AND HUMIDITY.
Special Storage Condition, SpecifyBetween 0 and 0 *AVOID DIRECT SUNLIGHT.
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT STORE AT EXTREME TEMPERATURES AND HUMIDITY.
Special Storage Condition, SpecifyBetween 0 and 0 *AVOID DIRECT SUNLIGHT.
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *DO NOT STORE AT EXTREME TEMPERATURES AND HUMIDITY.
Special Storage Condition, SpecifyBetween 0 and 0 *AVOID DIRECT SUNLIGHT.
Storage Environment TemperatureBetween 1 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104987350743251 [Primary]
GS154987350743256 [Package]
Contains: 04987350743251
Package: Carton [20 Units]
In Commercial Distribution

FDA Product Code

DTRHEAT-EXCHANGER, CARDIOPULMONARY BYPASS

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-28
Device Publish Date2024-05-20

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54987350703762Device Holder
54987350743256CAPIOX CARDIOPLEGIA

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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