Catalog Number

-

Brand Name

TENA

Version/Model Number

IDENTIFI SENSORWEAR L/XL

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

-

Product Code

KPN

Product Code Name

ALARM, CONDITIONED RESPONSE ENURESIS

Public Device Record Key

da39e3ac-6e08-4bd5-bf26-c056e77efe8c

Public Version Date

June 06, 2018

Public Version Number

3

DI Record Publish Date

September 16, 2016

Package DI Number

10768702600146

Quantity per Package

2

Contains DI Package

00768702600149

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case