Duns Number:062312574
Device Description: CVS WARMING JELLY 2.5 OZ - (CVS-097-2.5OZ)
Catalog Number
-
Brand Name
CVS Health
Version/Model Number
631788
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K052974,K052974
Product Code
NUC
Product Code Name
Lubricant, Personal
Public Device Record Key
a3b3048f-bf9a-4c57-b2e8-48ec7722f83b
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
50050428539519
Quantity per Package
24
Contains DI Package
00050428539514
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 82 |
2 | A medical device with a moderate to high risk that requires special controls. | 139 |
U | Unclassified | 23 |