Duns Number:092673953
Device Description: with Comfort Soft Plus adult non-vented mask, mouthpiece, B/V filter
Catalog Number
-
Brand Name
Circulaire II Aerosol Drug Delivery System
Version/Model Number
0330
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
CAF
Product Code Name
Nebulizer (Direct Patient Interface)
Public Device Record Key
8efff1f0-5ae6-40e7-85fc-6be0fa9eda0b
Public Version Date
December 22, 2021
Public Version Number
3
DI Record Publish Date
December 11, 2016
Package DI Number
10709078000789
Quantity per Package
25
Contains DI Package
00709078000782
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 | 746 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 320 |