Duns Number:008124539
Device Description: Resp-O2 Dry Bubble Humidifier, 400 mL, 6 PSI (Home Use)
Catalog Number
-
Brand Name
Resp-O2 Dry Bubble Humidifier
Version/Model Number
34221
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KFZ
Product Code Name
Humidifier, Non-Direct Patient Interface (Home-Use)
Public Device Record Key
7e0816c6-3ecd-4088-8042-75d564fda01d
Public Version Date
May 19, 2022
Public Version Number
1
DI Record Publish Date
May 11, 2022
Package DI Number
00840117308862
Quantity per Package
50
Contains DI Package
00840117308855
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 | 694 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 226 |
| 3 | A medical device with high risk that requires premarket approval | 2 |