Duns Number:185432994
Device Description: ENTRAINMENT NEBULIZER,BARREL STANDARD FLOW UP TO 12LPM AND 500ML BOTTLE COMBINATION
Catalog Number
P3000NB
Brand Name
CURAPLEX
Version/Model Number
301-P3000NB
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
K893942
Product Code
CAF
Product Code Name
Nebulizer (Direct Patient Interface)
Public Device Record Key
417e12a8-bbc5-4bcb-a124-ba026be63bf1
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
September 15, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |