Duns Number:200103823
Device Description: Flo2Max 5-in-1 Oxygen Mask, Large Adult
Catalog Number
6100
Brand Name
Rescuer Flo2Max Oxygen Mask
Version/Model Number
6100
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
80d24acc-5f67-4fee-9246-8ef5e1c73fc8
Public Version Date
October 30, 2020
Public Version Number
2
DI Record Publish Date
October 02, 2018
Package DI Number
B00261007
Quantity per Package
50
Contains DI Package
B00261000
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 |