Catalog Number

-

Brand Name

SteriGear

Version/Model Number

UE4001-00

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

FCN

Product Code Name

Urinary drainage collection kit, for indwelling catheter

Public Device Record Key

486593b5-6deb-4a8f-93e7-a422eb44e577

Public Version Date

May 19, 2021

Public Version Number

1

DI Record Publish Date

May 11, 2021

Package DI Number

10851616002561

Quantity per Package

20

Contains DI Package

00851616002564

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-