Duns Number:791014871
Device Description: Level 2 Face Mask with Earloop BLUE
Catalog Number
CM-101
Brand Name
Dukal
Version/Model Number
CM-101
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 22, 2022
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
K153496,K153496,K153496
Product Code
FXX
Product Code Name
Mask, surgical
Public Device Record Key
53e9a4dd-e209-4ddb-aeb7-aa3f2b695343
Public Version Date
May 23, 2022
Public Version Number
3
DI Record Publish Date
October 14, 2020
Package DI Number
60665973010375
Quantity per Package
6
Contains DI Package
70665973010372
Package Discontinue Date
March 22, 2022
Package Status
Not 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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 31 |
| U | Unclassified | 1 |