Duns Number:080314616
Device Description: Flex 16 count bag (English only)
Catalog Number
-
Brand Name
Flex
Version/Model Number
Flex 16 count bag (English only)
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)
-
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
-
Product Code
HHE
Product Code Name
Cup, Menstrual
Public Device Record Key
40354994-c2bc-48a7-af32-842a9bb36a27
Public Version Date
January 26, 2022
Public Version Number
3
DI Record Publish Date
August 30, 2018
Package DI Number
10851906007153
Quantity per Package
6
Contains DI Package
00851906007156
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. | 4 |