Duns Number:067692292
Device Description: Water-based Personal Lubricant
Catalog Number
-
Brand Name
JO H2O Flavored Tropical Passion 4oz/120ml
Version/Model Number
40121
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
NUC
Product Code Name
Lubricant, Personal
Public Device Record Key
dedf4f25-7a45-43f9-a2f9-9ad77237d24e
Public Version Date
September 09, 2022
Public Version Number
6
DI Record Publish Date
May 21, 2018
Package DI Number
B362401211
Quantity per Package
12
Contains DI Package
B362401210
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 199 |