Duns Number:006959555
Device Description: MEIJER PERSONAL LUBRICANT
Catalog Number
4156100
Brand Name
MEIJER
Version/Model Number
00760236441045
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
K150153
Product Code
NUC
Product Code Name
Lubricant, Personal
Public Device Record Key
23ecbdda-1a62-4a35-b1fd-d7aa8e0b5667
Public Version Date
March 17, 2022
Public Version Number
1
DI Record Publish Date
March 09, 2022
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 |