Catalog Number

KP2XLG02

Brand Name

CARDINAL HEALTH

Version/Model Number

KP2XLG02

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EYQ

Product Code Name

GARMENT, PROTECTIVE, FOR INCONTINENCE

Public Device Record Key

5f6df9b9-f76e-4624-beb4-a73180b5ec85

Public Version Date

May 15, 2020

Public Version Number

1

DI Record Publish Date

May 07, 2020

Package DI Number

50885380176249

Quantity per Package

50

Contains DI Package

20885380176248

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE