Duns Number:010712461
Device Description: Nebulizer, Small Volume, Handheld, Mouthpiece, Flextube, 7 ft Tubing, Universal Connector
Catalog Number
-
Brand Name
Curaplex
Version/Model Number
301-201EA
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
K800562,K800562
Product Code
CAF
Product Code Name
NEBULIZER (DIRECT PATIENT INTERFACE)
Public Device Record Key
f0a6b1ff-8862-4d28-9306-cdd658d141e5
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 06, 2017
Package DI Number
00812574026788
Quantity per Package
50
Contains DI Package
00812574026436
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 | 92 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 92 |