Catalog Number

-

Brand Name

HemoTemp II Activator

Version/Model Number

9000

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

-

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

da3f4d79-437f-454c-bf89-42c241f2fe2e

Public Version Date

August 30, 2022

Public Version Number

2

DI Record Publish Date

June 16, 2022

Package DI Number

10815236020923

Quantity per Package

1

Contains DI Package

00815236020926

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box