Duns Number:256880576
Device Description: Medicom SafeMask Junior - Pediatric Procedure Earloop Face Masks - Recommended age 4 to 12 Medicom SafeMask Junior - Pediatric Procedure Earloop Face Masks - Recommended age 4 to 12 years - Blue
Catalog Number
2035
Brand Name
Medicom SafeMask
Version/Model Number
2035
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
9b4308d2-c8ff-41c9-88bd-588b4d14d6ff
Public Version Date
May 20, 2022
Public Version Number
1
DI Record Publish Date
May 12, 2022
Package DI Number
20686864058223
Quantity per Package
10
Contains DI Package
10686864058226
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 |