Duns Number:070556204
Device Description: Curaplex CPAP Mask, Adult MED, Inflatable Cushion 50ea/cs
Catalog Number
-
Brand Name
Curaplex
Version/Model Number
71050
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
BZD
Product Code Name
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
Public Device Record Key
29743369-75ff-4c3c-b083-006ededdaacd
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 14, 2016
Package DI Number
00815277027373
Quantity per Package
50
Contains DI Package
00815277027366
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 | 471 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 540 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 1 |