Duns Number:658318113
Device Description: Copioumed Medical Mask is a disposable device intended to cover the mouth and nose of the Copioumed Medical Mask is a disposable device intended to cover the mouth and nose of the user to contain that user’s respiratory secretions, it provides a barrier to reduce the risk of spread of infective agents between staff and patient and protect patient during surgical procedures and other medical settings. This device is non-sterile and for single use only.
Catalog Number
-
Brand Name
Copioumed
Version/Model Number
MS012W
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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)
-
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
2a54a269-6bde-40e6-be21-e53e90ce021a
Public Version Date
August 30, 2022
Public Version Number
1
DI Record Publish Date
August 22, 2022
Package DI Number
14719882250177
Quantity per Package
10
Contains DI Package
04719882250170
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |