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
c0e7df2c-f93d-417f-847e-24a1e727b8d5
Public Version Date
March 17, 2021
Public Version Number
1
DI Record Publish Date
March 09, 2021
Package DI Number
20067981087998
Quantity per Package
6
Contains DI Package
10067981087991
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 24 |