Duns Number:783518983
Device Description: Your Nebulizer is intended for use in the treatment of asthma, COPD and other respiratory Your Nebulizer is intended for use in the treatment of asthma, COPD and other respiratory ailments in which an aerosolized medication is required during therapy. Please consult with your physician and/or pharmacist to determine if your prescription medication is approved for use with this Nebulizer. This Nebulizer is intended for single patient use.
Catalog Number
1607
Brand Name
Easy Air Compressor Nebulizer
Version/Model Number
MCN-S600MC
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"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CAF
Product Code Name
Nebulizer (Direct Patient Interface)
Public Device Record Key
965c2b99-57f1-47f6-8f1c-621246b68f20
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
May 01, 2016
Package DI Number
10891237001604
Quantity per Package
12
Contains DI Package
00891237001607
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 | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 44 |
| U | Unclassified | 11 |