Duns Number:002348191
Device Description: MADomizer Disposable Tip
Catalog Number
MAD510
Brand Name
LMA ATOMIZATION
Version/Model Number
IPN049183
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"
Yes
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
733882a9-40a1-4fb6-899b-4304c60dfe8d
Public Version Date
June 08, 2021
Public Version Number
4
DI Record Publish Date
February 15, 2018
Package DI Number
24026704626551
Quantity per Package
50
Contains DI Package
14026704626554
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Bag in Box
| 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 |