Duns Number:141668116
Device Description: Sunset Healthcare Solutions Deluxe Full Face CPAP Mask with Removable Cushion - Large *No Sunset Healthcare Solutions Deluxe Full Face CPAP Mask with Removable Cushion - Large *No Headgear*
Catalog Number
CM005LNH
Brand Name
Deluxe Full Face CPAP Mask with Removable Cushion - Large *No Headgear*
Version/Model Number
CM005LNH
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K063268
Product Code
BZD
Product Code Name
Ventilator, Non-Continuous (Respirator)
Public Device Record Key
eb221040-f98d-418e-ab1b-f1dadcc7aa94
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 160 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 68 |