Duns Number:040429050
Device Description: Adult Single Prong Hi-VNI Nasal Cannula
Catalog Number
-
Brand Name
Vapotherm
Version/Model Number
QSOFT-SOLO1700
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CAT
Product Code Name
Cannula, Nasal, Oxygen
Public Device Record Key
cb131c95-f1f8-49b3-a40f-b219b8a37b4f
Public Version Date
March 22, 2022
Public Version Number
3
DI Record Publish Date
April 01, 2018
Package DI Number
00841737102366
Quantity per Package
25
Contains DI Package
00841737102359
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 | 41 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 229 |