Duns Number:043833813
Device Description: AeroTech I Convenience Kit with small particle delivery system
Catalog Number
177-324
Brand Name
Aerotech I Radioaerosol Administration System
Version/Model Number
177-324
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K800023,K800023,K800023,K800023
Product Code
CAF
Product Code Name
Nebulizer (Direct Patient Interface)
Public Device Record Key
44b0bf87-9d2f-4ac7-b307-15461970be51
Public Version Date
September 06, 2018
Public Version Number
4
DI Record Publish Date
December 18, 2017
Package DI Number
20718175003262
Quantity per Package
10
Contains DI Package
00718175003244
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 193 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 52 |