Catalog Number
-
Brand Name
Vapotherm
Version/Model Number
AAA-1-BR
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)
Yes
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
8b4dc166-a827-44c1-b2cc-deae318e0c85
Public Version Date
October 10, 2022
Public Version Number
3
DI Record Publish Date
October 08, 2020
Package DI Number
10841737103674
Quantity per Package
10
Contains DI Package
00841737103677
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 |