BodyMed - BodyMed Digital Heating Pad 14"x27", black cover - BOXOUT, LLC

Duns Number:066689993

Device Description: BodyMed Digital Heating Pad 14"x27", black cover

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More Product Details

Catalog Number

ZZHP1427BLK

Brand Name

BodyMed

Version/Model Number

ZZHP1427BLK

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

-

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

IRT

Product Code Name

Pad, Heating, Powered

Device Record Status

Public Device Record Key

a8b4dc4f-e7bf-47ab-bbbe-86c49c955347

Public Version Date

February 27, 2020

Public Version Number

4

DI Record Publish Date

August 01, 2016

Additional Identifiers

Package DI Number

20815802018719

Quantity per Package

10

Contains DI Package

10815802018712

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master carton

"BOXOUT, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 23