Duns Number:062312574
Device Description: Waterproof MaxFlex Adhesive Bandages, all one size, 3 1/2 IN x 4 1/2 IN (88 mm x 114 mm),
Catalog Number
-
Brand Name
CVS Health
Version/Model Number
726708
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"
Yes
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
-
Product Code
KGX
Product Code Name
Tape And Bandage, Adhesive
Public Device Record Key
f6a7f5a6-dbde-4c3f-8571-ed1e0d14a5f6
Public Version Date
January 12, 2022
Public Version Number
1
DI Record Publish Date
January 04, 2022
Package DI Number
20050428642478
Quantity per Package
72
Contains DI Package
00050428642474
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 |