Duns Number:002348191
Device Description: UP-DRAFT II® OPTI-NEB® Small Volume Nebulizer
Catalog Number
1734
Brand Name
HUDSON RCI
Version/Model Number
IPN049797
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K760489,K760489,K760489
Product Code
CAF
Product Code Name
NEBULIZER (DIRECT PATIENT INTERFACE)
Public Device Record Key
6d6264bc-8a57-4bab-89d3-9d23256897f8
Public Version Date
June 10, 2022
Public Version Number
7
DI Record Publish Date
January 18, 2019
Package DI Number
24026704645835
Quantity per Package
50
Contains DI Package
14026704645838
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 | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |