Duns Number:062312574
Device Description: Dry Mouth SprayMint Flavor1.5 FL OZ (45 mL)
Catalog Number
-
Brand Name
CVS
Version/Model Number
DNE1317C1
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
-
Product Code
LFD
Product Code Name
Saliva, Artificial
Public Device Record Key
859598e5-e374-4754-8299-5c1c02dc64b5
Public Version Date
August 16, 2022
Public Version Number
1
DI Record Publish Date
August 08, 2022
Package DI Number
20050428379367
Quantity per Package
6
Contains DI Package
00050428293416
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 |