Duns Number:040429050
Device Description: HVT 2.0 Unit, VTU DISS (OUS)
Catalog Number
-
Brand Name
Vapotherm
Version/Model Number
HVT20-UNIT-VTU-DISS
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
-
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
9ca42cc2-7b1d-4fb3-8bbc-03aa3731e15f
Public Version Date
October 10, 2022
Public Version Number
2
DI Record Publish Date
November 15, 2021
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 |
---|---|---|
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 |