Duns Number:006959555
Device Description: Prefilled Disposable Personal Lubricant Applicator
Catalog Number
-
Brand Name
Meijer Vaginal Moisturizer Personal Lubricant
Version/Model Number
84010
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
January 01, 2030
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
K903910
Product Code
KMJ
Product Code Name
Lubricant, Patient
Public Device Record Key
1dfd8ac1-ddd0-4c59-9792-6c65de3b199f
Public Version Date
August 10, 2020
Public Version Number
1
DI Record Publish Date
July 31, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 37 |
2 | A medical device with a moderate to high risk that requires special controls. | 45 |
U | Unclassified | 1 |