Duns Number:185432994
Device Description: FLO2 STANDARD FLOW OXYGEN DILUTER, ADULT KIT
Catalog Number
P6200
Brand Name
PEGASUS
Version/Model Number
P6200
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
BYF
Product Code Name
Mask, Oxygen, Low Concentration, Venturi
Public Device Record Key
44d81c44-ca88-4ad6-9170-103fba38436c
Public Version Date
August 05, 2022
Public Version Number
2
DI Record Publish Date
September 17, 2021
Package DI Number
00612223062002
Quantity per Package
10
Contains DI Package
00612223062019
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 47 |