Catalog Number

UBH100

Brand Name

AMSure® Double Hanger for Economy Urinary Drainage Bags

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

-

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

KNX

Product Code Name

Collector, Urine, (And Accessories) For Indwelling Catheter

Public Device Record Key

312933db-367b-49a0-85c9-a6f865a9a773

Public Version Date

January 08, 2021

Public Version Number

3

DI Record Publish Date

October 30, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-