Catalog Number

-

Brand Name

BeKoool

Version/Model Number

667560060518

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)

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

fd82b6a3-c368-4bc7-be7c-07f4fb5f1725

Public Version Date

July 09, 2020

Public Version Number

1

DI Record Publish Date

July 01, 2020

Package DI Number

10667560060515

Quantity per Package

12

Contains DI Package

00667560060518

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box