Catalog Number

-

Brand Name

MYOtherm XP™

Version/Model Number

XP41T

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K162958,K162958

Product Code

DTN

Product Code Name

Reservoir, blood, cardiopulmonary bypass

Public Device Record Key

2f4586d2-6802-40e3-9fdc-6c4ded0c9ed1

Public Version Date

October 19, 2021

Public Version Number

2

DI Record Publish Date

August 06, 2020

Package DI Number

20763000219080

Quantity per Package

4

Contains DI Package

00763000219086

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PK