Catalog Number

-

Brand Name

Foley Catheter

Version/Model Number

21-035

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K082815,K082815

Product Code

EZL

Product Code Name

Catheter, Retention Type, Balloon

Public Device Record Key

64930263-75e3-4728-a514-97f36906c5fd

Public Version Date

December 04, 2020

Public Version Number

4

DI Record Publish Date

February 26, 2019

Package DI Number

10369771001089

Quantity per Package

10

Contains DI Package

00369771001082

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner