Duns Number:200103823
Device Description: Flo2Max 5-in-1 Oxygen Mask, Child
Catalog Number
6110
Brand Name
Flo2Max Oxygen Mask, Child
Version/Model Number
6110
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
bde86fa1-6291-4240-ac98-27578f1e7ab4
Public Version Date
October 30, 2020
Public Version Number
2
DI Record Publish Date
October 02, 2018
Package DI Number
B00266107
Quantity per Package
50
Contains DI Package
B00261100
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |