Catalog Number

-

Brand Name

BeKoool

Version/Model Number

667560060563

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

e8818e06-5882-47ef-ab13-533319f705f6

Public Version Date

February 03, 2021

Public Version Number

1

DI Record Publish Date

January 26, 2021

Package DI Number

10667560060560

Quantity per Package

24

Contains DI Package

00667560060563

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box