Duns Number:040429050
Device Description: Nitric Oxide Disposable Patient Circuit, Low Flow
Catalog Number
-
Brand Name
Vapotherm
Version/Model Number
PF-NODPC-LOW
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
K072845,K072845
Product Code
BTT
Product Code Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
Public Device Record Key
916f97e5-3387-48b1-992e-73f36e2ac5ac
Public Version Date
October 10, 2022
Public Version Number
6
DI Record Publish Date
August 05, 2016
Package DI Number
10841737100116
Quantity per Package
3
Contains DI Package
00841737100119
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| 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 |