Duns Number:185432994
Device Description: CURAPLEX ENTRAINMENT NEBULIZER, HIGH FLOW, UP TO 40 LPM, PACKAGED WITH 500ML BOTTLE
Catalog Number
301-P3000BH
Brand Name
CURAPLEX
Version/Model Number
P3000BHC
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
K962534,K962534
Product Code
CAF
Product Code Name
Nebulizer (Direct Patient Interface)
Public Device Record Key
124f24b9-a483-4990-8ffc-256de69a76e5
Public Version Date
June 10, 2022
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
612223300241
Quantity per Package
40
Contains DI Package
00612223300296
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 |