Duns Number:256880576
Device Description: Medicom Confidence - Earloop Face Masks - ASTM Level 3 Protection - Blue
Catalog Number
214115-CAN
Brand Name
Medicom Confidence
Version/Model Number
214115-CAN
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
FXX
Product Code Name
Mask, surgical
Public Device Record Key
4338089b-a1df-4d92-8786-bbc6d8136a84
Public Version Date
May 06, 2022
Public Version Number
1
DI Record Publish Date
April 28, 2022
Package DI Number
00686864059264
Quantity per Package
10
Contains DI Package
00686864059257
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 84 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 2 |