Catalog Number

-

Brand Name

Up&Up

Version/Model Number

245-07-1174

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

OMW

Product Code Name

Adhesive Backed Thermal Skin Patches

Public Device Record Key

59528444-8b13-4600-b0ae-c68474ea2219

Public Version Date

November 23, 2021

Public Version Number

1

DI Record Publish Date

November 15, 2021

Package DI Number

06945397903357

Quantity per Package

24

Contains DI Package

06945397903340

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

master carton