Catalog Number

-

Brand Name

NA

Version/Model Number

UDKNC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FCN

Product Code Name

Urinary Drainage Collection Kit, For Indwelling Catheter

Public Device Record Key

9cf996ec-5821-4d9d-a011-aaee1829d792

Public Version Date

December 04, 2020

Public Version Number

4

DI Record Publish Date

September 20, 2016

Package DI Number

10858778006499

Quantity per Package

5

Contains DI Package

00858778006492

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton