Catalog Number

0107001

Brand Name

Redicare

Version/Model Number

Instant Ice Pack 4" x 5"

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

IMD

Product Code Name

Pack, Hot Or Cold, Disposable

Public Device Record Key

a65e6e4b-6680-438a-858e-80f7fc384fb2

Public Version Date

August 05, 2020

Public Version Number

1

DI Record Publish Date

July 28, 2020

Package DI Number

B70901070011

Quantity per Package

112

Contains DI Package

B70901070010

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE