Sunbeam - Heated Mattress Pad - Jarden Consumer Solutions

Duns Number:001315134

Device Description: Heated Mattress Pad

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More Product Details

Catalog Number

-

Brand Name

Sunbeam

Version/Model Number

MSU7RTS-C000-15A38

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

a3b964b3-dc0c-45a7-88ed-b5d516ab58d4

Public Version Date

July 07, 2020

Public Version Number

3

DI Record Publish Date

September 22, 2016

Additional Identifiers

Package DI Number

10027045777534

Quantity per Package

2

Contains DI Package

00027045777537

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