Duns Number:783518983
Device Description: Mini Compressor Nebulizer. Portable and lightweight . AC powered. Child and Adult masks in Mini Compressor Nebulizer. Portable and lightweight . AC powered. Child and Adult masks included
Catalog Number
-
Brand Name
Pure Air Mini Nebulizer
Version/Model Number
MCN-S600A
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
be97f420-c6cc-4fe9-a0c2-b915e348f2ae
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
March 24, 2020
Package DI Number
10850632007550
Quantity per Package
32
Contains DI Package
00850632007553
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer Carton
| 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 |