Duns Number:078731530
Device Description: Pediatric Procedural Oxygen Mask - Medium Concentration
Catalog Number
-
Brand Name
Pedi-POM EZ-Lite
Version/Model Number
1003-PED
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"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BYG
Product Code Name
Mask, Oxygen
Public Device Record Key
3949c21d-f27d-4081-84e9-adb9ac6d1d0d
Public Version Date
August 13, 2018
Public Version Number
1
DI Record Publish Date
July 11, 2018
Package DI Number
20851438008090
Quantity per Package
30
Contains DI Package
10851438008093
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 12 |