Duns Number:002348191
Device Description: Neonatal Nebulizer Kit with Tee, 7ft Star Lumen® Tubing and Adapter
Catalog Number
1790
Brand Name
HUDSON RCI
Version/Model Number
IPN049801
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,K760489
Product Code
CAF
Product Code Name
NEBULIZER (DIRECT PATIENT INTERFACE)
Public Device Record Key
11832e31-83fb-4381-80a0-cf34bb8d7d4e
Public Version Date
September 28, 2022
Public Version Number
6
DI Record Publish Date
January 18, 2019
Package DI Number
24026704645866
Quantity per Package
50
Contains DI Package
14026704645869
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 |