Catalog Number

700-120 SMS

Brand Name

Streamline External Urine Management device

Version/Model Number

700-120

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

NZU

Product Code Name

Collector, urine, powered, non indwelling catheter

Public Device Record Key

c5d7bc35-745c-49ef-aeab-6b96d60b0ddf

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

May 24, 2022

Package DI Number

50618029980064

Quantity per Package

40

Contains DI Package

00618029980069

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case