CVS Health - Heat Therapy Patches Back & Large Areas - WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

Duns Number:062312574

Device Description: Heat Therapy Patches Back & Large Areas

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More Product Details

Catalog Number

-

Brand Name

CVS Health

Version/Model Number

868759

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

OMW

Product Code Name

Adhesive Backed Thermal Skin Patches

Device Record Status

Public Device Record Key

d15c0d52-104c-4b3a-8589-9ae59b767314

Public Version Date

August 17, 2020

Public Version Number

1

DI Record Publish Date

August 07, 2020

Additional Identifiers

Package DI Number

10050428327422

Quantity per Package

24

Contains DI Package

00050428327425

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"WOONSOCKET PRESCRIPTION CENTER, INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 82
2 A medical device with a moderate to high risk that requires special controls. 139
U Unclassified 23