Duns Number:002348191
Device Description: UP-DRAFT II® OPTI-NEB® Nebulizer with Adult Elongated Aerosol Mask and 7ft. (2.1m) Star Lu UP-DRAFT II® OPTI-NEB® Nebulizer with Adult Elongated Aerosol Mask and 7ft. (2.1m) Star Lumen® Tubing, ClearConnect™
Catalog Number
1705CC
Brand Name
HUDSON RCI
Version/Model Number
IPN049676
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"
Yes
For Single-Use
Yes
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
K760489,K760489
Product Code
CAF
Product Code Name
NEBULIZER (DIRECT PATIENT INTERFACE)
Public Device Record Key
e7fc0945-20d9-4c1a-b657-e320b2410304
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
September 15, 2018
Package DI Number
34026704642602
Quantity per Package
50
Contains DI Package
14026704642608
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 |