Duns Number:054318779
Device Description: Mesh Cap for NE-U100 (MicroAir Vibrating Mesh Nebulizer)
Catalog Number
U100-4
Brand Name
Mesh Cap
Version/Model Number
U100-4
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
K062263,K062263
Product Code
CAF
Product Code Name
Nebulizer (Direct Patient Interface)
Public Device Record Key
6b3684d1-3898-4af8-b2b0-837fcca7c0b0
Public Version Date
December 03, 2018
Public Version Number
1
DI Record Publish Date
October 31, 2018
Package DI Number
10073796011045
Quantity per Package
400
Contains DI Package
00073796011048
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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |