Catalog Number

-

Brand Name

HemoTemp II

Version/Model Number

HemoTemp II

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

KSS

Product Code Name

Supplies, Blood-Bank

Public Device Record Key

f37e825e-f7d3-47dc-ad7b-5fffd220572a

Public Version Date

February 22, 2022

Public Version Number

1

DI Record Publish Date

February 14, 2022

Package DI Number

10815236021067

Quantity per Package

40

Contains DI Package

00815236021060

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box