Duns Number:256880576
Device Description: SAFEMASK FREEFLOW PROCEDURE EARLOOP MASK L1 - PINK
Catalog Number
20316
Brand Name
MEDICOM SAFEMASK FREEFLOW
Version/Model Number
200316
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
ca8715dc-b530-4e0b-b426-c5ef40dd422a
Public Version Date
April 19, 2022
Public Version Number
4
DI Record Publish Date
May 14, 2020
Package DI Number
20686864056380
Quantity per Package
10
Contains DI Package
10686864056383
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 |