MYOtherm XP™

GUDID 20763000218991

HEAT EXCHANGER CBXP41B MYOTHERM INC 4PK

MEDTRONIC, INC.

Cardioplegia solution administration kit Cardioplegia solution administration kit Cardioplegia solution administration kit Cardioplegia solution administration kit Cardioplegia solution administration kit Cardioplegia solution administration kit Cardioplegia solution administration kit Cardioplegia solution administration kit Cardioplegia solution administration kit Cardioplegia solution administration kit Cardioplegia solution administration kit Cardioplegia solution administration kit Cardioplegia solution administration kit Cardioplegia solution administration kit Cardioplegia solution administration kit
Primary Device ID20763000218991
NIH Device Record Key03f3dabf-6c16-4d59-91c9-0db13b3ae6ef
Commercial Distribution StatusIn Commercial Distribution
Brand NameMYOtherm XP™
Version Model NumberCBXP41B
Company DUNS006261481
Company NameMEDTRONIC, INC.
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000218997 [Primary]
GS100763000218997 [Primary]
GS100763000218997 [Primary]
GS100763000218997 [Primary]
GS100763000218997 [Primary]
GS100763000218997 [Primary]
GS100763000218997 [Primary]
GS100763000218997 [Primary]
GS100763000218997 [Primary]
GS100763000218997 [Primary]
GS100763000218997 [Primary]
GS100763000218997 [Primary]
GS100763000218997 [Primary]
GS100763000218997 [Primary]
GS100763000218997 [Primary]
GS120763000218991 [Package]
Contains: 00763000218997
Package: PK [4 Units]
In Commercial Distribution
GS120763000218991 [Package]
Contains: 00763000218997
Package: PK [4 Units]
In Commercial Distribution
GS120763000218991 [Package]
Contains: 00763000218997
Package: PK [4 Units]
In Commercial Distribution
GS120763000218991 [Package]
Contains: 00763000218997
Package: PK [4 Units]
In Commercial Distribution
GS120763000218991 [Package]
Contains: 00763000218997
Package: PK [4 Units]
In Commercial Distribution
GS120763000218991 [Package]
Contains: 00763000218997
Package: PK [4 Units]
In Commercial Distribution
GS120763000218991 [Package]
Contains: 00763000218997
Package: PK [4 Units]
In Commercial Distribution
GS120763000218991 [Package]
Contains: 00763000218997
Package: PK [4 Units]
In Commercial Distribution
GS120763000218991 [Package]
Contains: 00763000218997
Package: PK [4 Units]
In Commercial Distribution
GS120763000218991 [Package]
Contains: 00763000218997
Package: PK [4 Units]
In Commercial Distribution
GS120763000218991 [Package]
Contains: 00763000218997
Package: PK [4 Units]
In Commercial Distribution
GS120763000218991 [Package]
Contains: 00763000218997
Package: PK [4 Units]
In Commercial Distribution
GS120763000218991 [Package]
Contains: 00763000218997
Package: PK [4 Units]
In Commercial Distribution
GS120763000218991 [Package]
Contains: 00763000218997
Package: PK [4 Units]
In Commercial Distribution
GS120763000218991 [Package]
Contains: 00763000218997
Package: PK [4 Units]
In Commercial Distribution

FDA Product Code

DTRHEAT-EXCHANGER, CARDIOPULMONARY BYPASS
DTRHEAT-EXCHANGER, CARDIOPULMONARY BYPASS
DTRHEAT-EXCHANGER, CARDIOPULMONARY BYPASS
DTRHEAT-EXCHANGER, CARDIOPULMONARY BYPASS
DTRHEAT-EXCHANGER, CARDIOPULMONARY BYPASS
DTRHEAT-EXCHANGER, CARDIOPULMONARY BYPASS
DTRHEAT-EXCHANGER, CARDIOPULMONARY BYPASS
DTRHEAT-EXCHANGER, CARDIOPULMONARY BYPASS
DTRHEAT-EXCHANGER, CARDIOPULMONARY BYPASS
DTRHEAT-EXCHANGER, CARDIOPULMONARY BYPASS
DTRHEAT-EXCHANGER, CARDIOPULMONARY BYPASS
DTRHEAT-EXCHANGER, CARDIOPULMONARY BYPASS
DTRHEAT-EXCHANGER, CARDIOPULMONARY BYPASS
DTRHEAT-EXCHANGER, CARDIOPULMONARY BYPASS
DTRHEAT-EXCHANGER, CARDIOPULMONARY BYPASS

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-23
Device Publish Date2020-06-15

On-Brand Devices [MYOtherm XP™]

20643169766932HEAT EXCHANGER CBXP41B MYOTHERM INC 4PK
20643169766918HEAT EXCHANGER CBXP41 MYOTHERM INC 4PK
20763000218991HEAT EXCHANGER CBXP41B MYOTHERM INC 4PK
20763000218953HEAT EXCHANGER CBXP41 MYOTHERM INC 4PK

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.