Sunbeam - FlexTemp Hot/Cold Joint Wrap - Jarden Consumer Solutions

Duns Number:001315134

Device Description: FlexTemp Hot/Cold Joint Wrap

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More Product Details

Catalog Number

-

Brand Name

Sunbeam

Version/Model Number

053891136938

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)

-

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

b036d26c-44db-4bc5-b68b-4d70f518465c

Public Version Date

July 07, 2020

Public Version Number

2

DI Record Publish Date

July 18, 2019

Additional Identifiers

Package DI Number

40053891136936

Quantity per Package

4

Contains DI Package

00053891136938

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"JARDEN CONSUMER SOLUTIONS" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 23
2 A medical device with a moderate to high risk that requires special controls. 164