Duns Number:256880576
Device Description: ASSUREMASK BALANCE - PROCEDURE EARLOOP FACE MASK - LEVEL 2 - PINK
Catalog Number
205516
Brand Name
MEDICOM ASSUREMASK BALANCE
Version/Model Number
205516
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
f587f6c9-3177-43ac-b01b-2d93d2957866
Public Version Date
April 27, 2022
Public Version Number
2
DI Record Publish Date
March 09, 2021
Package DI Number
20686864057363
Quantity per Package
10
Contains DI Package
10686864057366
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 |