Duns Number:656413127
Device Description: WIZARD 510 Nasal Mask is intended to provide an interface for Continuous Positive Airway P WIZARD 510 Nasal Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. The nasal mask is intended for single-patient reuse in the home and multi-patient, multi-use in the hospital environment. The nasal mask is to be used on patients greater than 30 kg for whom positive airway pressure (CPAP or bi-level system) has been prescribed.
Catalog Number
-
Brand Name
APEX
Version/Model Number
WiZARD 510 L size
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
-
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
K193206,K193206
Product Code
BZD
Product Code Name
Ventilator, Non-Continuous (Respirator)
Public Device Record Key
8b91c940-8d82-4151-bc95-840ea9d3837e
Public Version Date
July 19, 2022
Public Version Number
1
DI Record Publish Date
July 11, 2022
Package DI Number
14713025001862
Quantity per Package
60
Contains DI Package
04713025001865
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 55 |