Duns Number:062312574
Device Description: 3% Hydrogen Peroxide Solution, Cleaning & Disinfecting Lens Care System. 12 FL oz. (355mL 3% Hydrogen Peroxide Solution, Cleaning & Disinfecting Lens Care System. 12 FL oz. (355mL)
Catalog Number
-
Brand Name
CVS Health
Version/Model Number
694689
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
-
Product Code
LPN
Product Code Name
Accessories, Soft Lens Products
Public Device Record Key
1092d54e-7010-4861-8bd2-638c0dbe13e1
Public Version Date
April 21, 2020
Public Version Number
1
DI Record Publish Date
April 13, 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 | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139 |
| U | Unclassified | 23 |