Duns Number:132016168
Device Description: Neb-u-Lite LX Nebulizer Compressor
Catalog Number
-
Brand Name
JOHN BUNN
Version/Model Number
JB0112-110
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K161586,K161586
Product Code
CAF
Product Code Name
Nebulizer (Direct Patient Interface)
Public Device Record Key
ed8b213f-2216-46bb-b69c-53404fc786b1
Public Version Date
June 10, 2022
Public Version Number
6
DI Record Publish Date
August 31, 2016
Package DI Number
M368JB01121102
Quantity per Package
6
Contains DI Package
M368JB01121101
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1068 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 202 |