Catalog Number

-

Brand Name

HemoTemp

Version/Model Number

2000

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

-

Product Code

KSE

Product Code Name

Refrigerator, Freezer, Blood Storage

Public Device Record Key

1903528d-8bb2-4dc1-936c-6cfaf7b03ead

Public Version Date

June 28, 2022

Public Version Number

1

DI Record Publish Date

June 20, 2022

Package DI Number

20815236021057

Quantity per Package

5

Contains DI Package

10815236021050

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case