Duns Number:879057065
Device Description: A water based personal lubricant that is compatible with latex and polyurethane condoms.
Catalog Number
-
Brand Name
Lush
Version/Model Number
Lush 17 fl oz Water Based Lubricant
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K051295,K051295
Product Code
NUC
Product Code Name
Lubricant, Personal
Public Device Record Key
c8213e0e-318a-48ee-8d60-b3b693f34de4
Public Version Date
August 07, 2020
Public Version Number
5
DI Record Publish Date
April 21, 2017
Package DI Number
30864785000218
Quantity per Package
12
Contains DI Package
00864785000217
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. | 56 |