Catalog Number

-

Brand Name

Flo-Assist II

Version/Model Number

7-510-49

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

LJH

Product Code Name

System, Irrigation, Urological

Public Device Record Key

36c3802f-0761-448c-9143-eac44f1ac1cd

Public Version Date

April 23, 2019

Public Version Number

4

DI Record Publish Date

October 14, 2016

Package DI Number

10817183020360

Quantity per Package

10

Contains DI Package

00817183020363

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-