Duns Number:141668116
Device Description: Sunset Healthcare Solutions Deluxe Nasal Pillow CPAP Mask. Includes 1 Mask Frame with Hea Sunset Healthcare Solutions Deluxe Nasal Pillow CPAP Mask. Includes 1 Mask Frame with Headgear, replaceable Small, Medium and Large Nasal Pillows and SHS Labeled Bag
Catalog Number
CM036
Brand Name
Deluxe Nasal Pillow CPAP Mask
Version/Model Number
CM036
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"
-
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
-
Product Code
BZD
Product Code Name
Ventilator, Non-Continuous (Respirator)
Public Device Record Key
08b3472d-e081-4a8f-9d3e-2f3272523475
Public Version Date
August 21, 2018
Public Version Number
4
DI Record Publish Date
March 01, 2017
Package DI Number
10848530085862
Quantity per Package
50
Contains DI Package
00848530085865
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 | 160 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 68 |