Catalog Number

86022

Brand Name

Hemotherm

Version/Model Number

400CE

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

DWC

Product Code Name

Controller, Temperature, Cardiopulmonary Bypass

Public Device Record Key

7ee2a50e-65ed-460e-a56c-29a038bfe6d4

Public Version Date

September 23, 2021

Public Version Number

5

DI Record Publish Date

October 06, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-