Duns Number:078758082
Device Description: The Ventec High Flow Nasal Cannula Kit contains the following items:- 5x Adult, Valveless The Ventec High Flow Nasal Cannula Kit contains the following items:- 5x Adult, Valveless Heated Ventec One-Circuit (00855573007235)- 5x Humidifier Bypass (00855573007136)- 5x Optiflow+ Adult Cannula, Medium (09420012429117)- 5x Auto-fill Disposable Adult Humidification Chamber (09420012432025)- 1x High Pressure O2 Hose (14896138006587)- 1x Temperature Probe (09420012401311)- 1x 850 Heater Wire Adapter (09420012421548)- 1x Water Bag Pole (09420012405920)- 1x MR850 Heated Humidifier (09420012407290)
Catalog Number
PRT-01264-000
Brand Name
VOCSN High Flow Kit
Version/Model Number
5-Week High Flow Nasal Cannula Kit
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BTT
Product Code Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
Public Device Record Key
acefbf33-e1e9-4aa2-87ad-150688cbbd9f
Public Version Date
October 13, 2020
Public Version Number
1
DI Record Publish Date
October 05, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 43 |