Duns Number:203298203
Device Description: MC 300* Reusable Nebulizer with Mouthpiece
Catalog Number
10555294050
Brand Name
MC 300*R Nebulizer with Mouthpiece
Version/Model Number
105552
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 22, 2020
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
-
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
K173825,K173825
Product Code
CAF
Product Code Name
Nebulizer (Direct Patient Interface)
Public Device Record Key
b85d0473-2b19-4660-a03a-d8f8c35b7f19
Public Version Date
April 23, 2020
Public Version Number
3
DI Record Publish Date
June 29, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 21 |