Duns Number:262411625
Device Description: GoodKnight H2O is a heated humidifier designed to be used with PAP devices of the GoodKnig GoodKnight H2O is a heated humidifier designed to be used with PAP devices of the GoodKnight series.
Catalog Number
M-114600
Brand Name
GoodKnight
Version/Model Number
GoodKnight H2O
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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
a531cfff-8348-40d0-9604-ac5dfdd5d163
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 10, 2016
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. | 20 |