Catalog Number

KP2XLG

Brand Name

CARDINAL HEALTH

Version/Model Number

KP2XLG

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"

Yes

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

dcfdcb73-a96d-4575-bf0e-5a9582ed2786

Public Version Date

February 25, 2020

Public Version Number

1

DI Record Publish Date

February 17, 2020

Package DI Number

50192253014332

Quantity per Package

20

Contains DI Package

20192253014331

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE