Catalog Number

-

Brand Name

Heating pad

Version/Model Number

CH2

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

IRT

Product Code Name

Pad, Heating, Powered

Public Device Record Key

756d1654-716c-491e-8036-e82e4eac84f9

Public Version Date

September 23, 2020

Public Version Number

1

DI Record Publish Date

September 15, 2020

Package DI Number

16955293916914

Quantity per Package

6

Contains DI Package

06955293916917

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-