Catalog Number

-

Brand Name

HemoTemp II Activator

Version/Model Number

9000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 12, 2022

Issuing Agency

In HIBCC

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

-

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

JRG

Product Code Name

Block, Heating

Public Device Record Key

f01275e6-f513-44a6-9505-a306ab7b0a51

Public Version Date

August 30, 2022

Public Version Number

5

DI Record Publish Date

June 01, 2017

Package DI Number

M74490001

Quantity per Package

1

Contains DI Package

M74490000

Package Discontinue Date

February 12, 2022

Package Status

Not in Commercial Distribution

Package Type

Box