Duns Number:185432994
Device Description: CONTINUOUS NEBULIZER KIT, STANDARD FLOW UP TO 12LPM, WITH ADULT MASK
Catalog Number
P3100NAKA
Brand Name
CURAPLEX RES-Q
Version/Model Number
301-0909MA
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
K122857,K122857
Product Code
CAF
Product Code Name
Nebulizer (Direct Patient Interface)
Public Device Record Key
ddc2e1d1-c93b-4f20-977b-5f8edc37cbe1
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
612223310141
Quantity per Package
10
Contains DI Package
00612223310196
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 47 |