Catalog Number

LBE308N

Brand Name

AMSure® Urinary Leg Bag with Extension Tube

Version/Model Number

1

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

FAQ

Product Code Name

Bag, Urine Collection, Leg, For External Use, Sterile

Public Device Record Key

09800890-1125-4426-a884-0ebb43dbb4b8

Public Version Date

April 07, 2021

Public Version Number

5

DI Record Publish Date

July 01, 2017

Package DI Number

40704411006276

Quantity per Package

48

Contains DI Package

10704411006275

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case