Catalog Number

AS89314H

Brand Name

AMSure ® Foley Catheters Tray

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

-

Product Code

FCM

Product Code Name

Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)

Public Device Record Key

abf3b586-c913-453d-bb33-c73255cc3864

Public Version Date

April 12, 2022

Public Version Number

1

DI Record Publish Date

April 04, 2022

Package DI Number

40704411014851

Quantity per Package

10

Contains DI Package

10704411014850

Package Discontinue Date

March 01, 2022

Package Status

Not in Commercial Distribution

Package Type

case