MYOtherm XP - DELIVERY LINE 61399401032 4PK MYOTHERMXP - MEDTRONIC, INC.

Duns Number:006261481

Device Description: DELIVERY LINE 61399401032 4PK MYOTHERMXP

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More Product Details

Catalog Number

-

Brand Name

MYOtherm XP

Version/Model Number

61399401032

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K971105,K971105

Product Code Details

Product Code

DTN

Product Code Name

RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS

Device Record Status

Public Device Record Key

0c107ed6-f105-4645-9c34-c7d2fae5cecf

Public Version Date

October 19, 2021

Public Version Number

4

DI Record Publish Date

June 17, 2016

Additional Identifiers

Package DI Number

50613994010327

Quantity per Package

4

Contains DI Package

30613994010323

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PK

"MEDTRONIC, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 102
2 A medical device with a moderate to high risk that requires special controls. 20495
3 A medical device with high risk that requires premarket approval 3601