MYOtherm XP®

Basic Information

• Brand Name: MYOtherm XP®
• Primary DI: 00613994947758
• Version / Model: 61399404996
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 006261481
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-16
• Public Version: 4
• Public Version Date: 2021-10-19
• Public Version Status: Update
• Public Device Record Key: f1415a13-1aa6-443b-8ffb-bb7ffb4cc2e7

Device Description

CARDIOPLEGIA 61399404996 MYO XP 4:1 4PK

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	20613994947752	GS1	PK	4	In Commercial Distribution
Primary	00613994947758	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K971105	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 50 Degrees Celsius