Duns Number:656413127
Device Description: Nasal Pillows Mask with Headgear (Mr.: S, M, L)
Catalog Number
-
Brand Name
APEX
Version/Model Number
WiZARD 230
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
K121642,K121642
Product Code
BZD
Product Code Name
Ventilator, Non-Continuous (Respirator)
Public Device Record Key
9a778cbc-c2aa-4488-a811-5e28eacb7496
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
14713025000612
Quantity per Package
25
Contains DI Package
04713025000615
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 |