Catalog Number

-

Brand Name

AMSure ® Hydrophilic Latex Foley Catheters

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)

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

K091699,K091699

Product Code

EZL

Product Code Name

Catheter, Retention Type, Balloon

Public Device Record Key

ae476d62-e031-422f-ac21-9bdd4be6c735

Public Version Date

January 17, 2022

Public Version Number

1

DI Record Publish Date

January 07, 2022

Package DI Number

40704411008959

Quantity per Package

200

Contains DI Package

10704411008958

Package Discontinue Date

December 25, 2021

Package Status

Not in Commercial Distribution

Package Type

case