AccessGUDID - DEVICE: MyOtherm XP® (00613994947741)

GUDID

Device Identifier (DI) Information

Brand Name: MyOtherm XP®
Version or Model: 61399405331
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC, INC.

Primary DI Number: 00613994947741
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006261481 *Terms of Use

Device Description: CARDIOPLEGIA 61399405331 MYO XP 4:1B 4PK

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DTN	RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K971105	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: less than 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 83ef0eb6-9d81-4f74-ac87-90ddd6f880eb
Public Version Date: October 07, 2024
Public Version Number: 5
DI Record Publish Date: September 23, 2014

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20613994947745	4	00613994947741		In Commercial Distribution	PK

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)633-8766
Email: Corporate.UDI@medtronic.com

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