BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

MYOtherm XP™

DI: 00763000219086 · Model: XP41T · MEDTRONIC, INC.

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Product Codes

1

GMDN Terms

1

Identifiers

2

Pkg Device Count

1

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Basic Information

Brand Name: MYOtherm XP™
Primary DI: 00763000219086
Version / Model: XP41T
Company Name: MEDTRONIC, INC.
Labeler DUNS: 006261481
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2020-08-06
Public Version: 3
Public Version Date: 2025-09-15
Public Version Status: Update
Public Device Record Key: 2f4586d2-6802-40e3-9fdc-6c4ded0c9ed1
Distribution End Date: 2025-09-11

Device Description

TRILLIUM MYOTHERM XP41T

Device Characteristics

Single Use: Yes
Prescription Use (Rx): No
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: No
Has Expiration Date: No
Has Donation ID: No

Sterilization

Is Sterile: Yes
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DTN	Reservoir, blood, cardiopulmonary bypass	Cardiovascular	870.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16163	Cardioplegia solution administration kit	A collection of devices intended to be used to infuse cardioplegia solution into the heart to interrupt its contractions during cardiopulmonary bypass surgery. It typically consists of tubing/adaptor, a filter, and a heat exchanger. This is single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20763000219080	GS1	PK	4	Not in Commercial Distribution	2025-09-11
Primary	00763000219086	GS1

Customer Contacts

Phone: +1(800)633-8766
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K162958	000

Storage Conditions

Type: Special Storage Condition, Specify
Special Conditions: Store the product at room temperature.
Type: Handling Environment Temperature
Temperature Range: – 50 Degrees Celsius