Duns Number:256880576
Device Description: SAFEMASK PREMIER Pediatric Procedure Masks Earloop L1/Recommended age: 4 -12
Catalog Number
2038
Brand Name
MEDICOM SAFEMASK PREMIER
Version/Model Number
2038
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
OXZ
Product Code Name
Pediatric/Child Facemask
Public Device Record Key
df349906-e2f6-4067-bc24-d10905ddd35c
Public Version Date
April 27, 2022
Public Version Number
2
DI Record Publish Date
October 30, 2020
Package DI Number
20686864056731
Quantity per Package
10
Contains DI Package
10686864056734
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 |