Catalog Number

-

Brand Name

BackAid

Version/Model Number

A1750008

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

OMW

Product Code Name

Adhesive Backed Thermal Skin Patches

Public Device Record Key

d057b104-a7db-40ea-bdd9-5fec706fad0e

Public Version Date

May 26, 2022

Public Version Number

1

DI Record Publish Date

May 18, 2022

Package DI Number

10072959010758

Quantity per Package

24

Contains DI Package

00072959010751

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-