MYOtherm XP™

GUDID 20763000219080

TRILLIUM MYOTHERM XP41T

MEDTRONIC, INC.

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Primary Device ID20763000219080
NIH Device Record Key2f4586d2-6802-40e3-9fdc-6c4ded0c9ed1
Commercial Distribution StatusIn Commercial Distribution
Brand NameMYOtherm XP™
Version Model NumberXP41T
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 Perscriptionfalse
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
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

Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the product at room temperature.

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000219086 [Primary]
GS120763000219080 [Package]
Contains: 00763000219086
Package: PK [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-14
Device Publish Date2020-08-06

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
20763000219080TRILLIUM MYOTHERM XP41T
20763000218342CARDIOPLEGIA XP41BT MYOTHERM XP4 1BT 4PK

Trademark Results [MYOtherm XP]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MYOTHERM XP
MYOTHERM XP
75390353 2289454 Live/Registered
MEDTRONIC INTERNATIONAL TRADING, INC.
1997-11-14

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