Catalog Number

UK5.0

Brand Name

NEOMED*

Version/Model Number

UK5.0

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

-

Product Code

FCN

Product Code Name

Urinary drainage collection kit, for indwelling catheter

Public Device Record Key

60791c13-2d06-43b6-89ff-cc2075b4abfb

Public Version Date

September 06, 2021

Public Version Number

1

DI Record Publish Date

August 27, 2021

Package DI Number

10350770003402

Quantity per Package

5

Contains DI Package

00350770003405

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS