Catalog Number

-

Brand Name

SIM assessPLUS sensor pad kit - LIGHT

Version/Model Number

6027

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K130951

Product Code

KPN

Product Code Name

Alarm, Conditioned Response Enuresis

Public Device Record Key

339f5f01-3472-43b9-9d58-35d87562d6cd

Public Version Date

June 21, 2021

Public Version Number

5

DI Record Publish Date

August 16, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-