Catalog Number

-

Brand Name

DUREX Air Condom

Version/Model Number

Condom

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K200672,K200672,K200672,K200672

Product Code

HIS

Product Code Name

CONDOM

Public Device Record Key

e95bcf1b-6856-464b-9258-6b4e18751cab

Public Version Date

March 17, 2021

Public Version Number

1

DI Record Publish Date

March 09, 2021

Package DI Number

20067981087981

Quantity per Package

6

Contains DI Package

10067981087984

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case