Duns Number:867673159
Device Description: RespiratoryNebs Product Description: Power Neb Ultra, w/PedMask 1/ea, 6/cv
Catalog Number
-
Brand Name
DRIVEMEDICAL
Version/Model Number
18080P
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
CAF
Product Code Name
NEBULIZER (DIRECT PATIENT INTERFACE)
Public Device Record Key
be076884-031f-4b72-b385-a178980ea137
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
June 21, 2019
Package DI Number
50822383975479
Quantity per Package
6
Contains DI Package
00822383975474
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 | 3783 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 832 |