Duns Number:062312574
Device Description: Extra Strength Nasal Strips, Clear Strips
Catalog Number
-
Brand Name
CVS Health
Version/Model Number
542630
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
LWF
Product Code Name
Dilator, Nasal
Public Device Record Key
d98f1d68-1c34-425c-9945-ace166a81c2f
Public Version Date
October 08, 2019
Public Version Number
1
DI Record Publish Date
September 30, 2019
Package DI Number
20005042830862
Quantity per Package
36
Contains DI Package
00050428308615
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 |