Duns Number:002348191
Device Description: MADomizer Disposable Tip
Catalog Number
AMZ510SU
Brand Name
LMA ATOMIZATION
Version/Model Number
IPN056575
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
Yes
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
-
Product Code
CCQ
Product Code Name
NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER)
Public Device Record Key
197cbf4c-e363-40b5-b048-14d8622d4f89
Public Version Date
June 08, 2021
Public Version Number
2
DI Record Publish Date
July 30, 2020
Package DI Number
34026704717584
Quantity per Package
4
Contains DI Package
24026704717587
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 | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |