Duns Number:357007657
Device Description: Respiratory Gas Humidifier
Catalog Number
003530
Brand Name
HA01
Version/Model Number
US
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 16, 2021
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
940c4cb5-b255-4b59-b974-2613f531d279
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
September 20, 2016
Package DI Number
07321822110160
Quantity per Package
1
Contains DI Package
07321820035304
Package Discontinue Date
December 16, 2021
Package Status
Not in Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 76 |