MYOtherm XP®

FDA UDI

Class II (US FDA UDI)

by Medtronic, Inc.

Identity

Trade Name: MYOtherm XP® FDA UDI
Generic Name: Cardioplegia solution administration kit FDA UDI
Device Name: CARDIOPLEGIA 61399404996 MYO XP 4:1 4PK FDA UDI
Model / Reference: 61399404996 FDA UDI
Description: CARDIOPLEGIA 61399404996 MYO XP 4:1 4PK FDA UDI

Identifiers

Primary DI / UDI-DI: 00613994947758 FDA UDI
510(k) Number: K971105 FDA UDI
FDA Product Code: DTN FDA UDI
GMDN Term: Cardioplegia solution administration kit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.4400 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Cardioplegia solution administration kit

MYOtherm XP® by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardioplegia solution administration kit.

Cardiovascular Procedure Kit — Terumo Cardiovascular Systems Corporation · Class II
Sarns™ Cardioplegia Set — Terumo Cardiovascular Systems Corporation · Class II
MPS 3 ND Delivery Set w/AA w/106cm (16C) — QUEST MEDICAL INC · Class II
MPS® Low Volume Delivery Set — QUEST MEDICAL INC · Class II
MPS 3 Additive Delivery Line — QUEST MEDICAL INC · Class II
MPS — QUEST MEDICAL INC · Class II
MPS 3 ND Delivery Set w/AA w/183 Line (16C) — QUEST MEDICAL INC · Class II
Sarns™ Cardioplegia Set — Terumo Cardiovascular Systems Corporation · Class I

Cleared under the same submission

K971105 also covers:

MYOtherm XP — MEDTRONIC, INC.
MyOtherm XP® — MEDTRONIC, INC.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Medtronic, Inc.

Sources (1)

FDA UDI f1415a13-1aa6-443b-8ffb-bb7ffb4cc2e7 36 fields · synced Jun 8, 2026