Duns Number:002348191
Device Description: MICRO MIST® Nebulizer with Elongated Adult Aerosol Mask and 7ft Star Lumen® Tubing
Catalog Number
1885
Brand Name
HUDSON RCI
Version/Model Number
IPN049807
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
K930525,K930525,K930525
Product Code
CAF
Product Code Name
NEBULIZER (DIRECT PATIENT INTERFACE)
Public Device Record Key
3f597cc6-5486-414f-a796-b54eabe4e7d2
Public Version Date
June 10, 2022
Public Version Number
8
DI Record Publish Date
January 18, 2019
Package DI Number
24026704645927
Quantity per Package
50
Contains DI Package
14026704645920
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 |