Duns Number:867673159
Device Description: RespiratoryNebs Product Description: 18081-IHO (102280), 6/cv
Catalog Number
-
Brand Name
DRIVEMEDICAL
Version/Model Number
18081-IHO
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 03, 2018
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
K161586,K161586
Product Code
CAF
Product Code Name
NEBULIZER (DIRECT PATIENT INTERFACE)
Public Device Record Key
48475ab3-96d2-464c-be58-22872bafbfe8
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
50822383563065
Quantity per Package
6
Contains DI Package
00822383563060
Package Discontinue Date
September 03, 2018
Package Status
Not 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 |