Duns Number:092673953
Device Description: Mask, Pediatric Non-Rebreather W/Safety Vent,7' KROT, and TN
Catalog Number
-
Brand Name
MADA Non-Rebreather Masks
Version/Model Number
53226
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KGB
Product Code Name
Mask, Oxygen, Non-Rebreathing
Public Device Record Key
12527d51-2402-49aa-988f-a8fa280480f4
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
April 14, 2017
Package DI Number
10709078002523
Quantity per Package
50
Contains DI Package
00709078002526
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 | 746 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 320 |