Catalog Number

-

Brand Name

TopCare health

Version/Model Number

036800281516

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

e35a0d97-a308-4a38-b4a7-fca671f7a6fb

Public Version Date

August 10, 2020

Public Version Number

1

DI Record Publish Date

July 31, 2020

Package DI Number

20036800281510

Quantity per Package

24

Contains DI Package

00036800281516

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box