Duns Number:141668116
Device Description: Sunset Healthcare Solutions Deluxe Nasal CPAP Mask with Removable Cushion, Headgear and SH Sunset Healthcare Solutions Deluxe Nasal CPAP Mask with Removable Cushion, Headgear and SHS Labeled Bag - Large
Catalog Number
CM006L
Brand Name
Deluxe Nasal CPAP Mask with Removable Cushion - Large
Version/Model Number
CM006L
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
K063268,K063268
Product Code
BZD
Product Code Name
Ventilator, Non-Continuous (Respirator)
Public Device Record Key
da5a4290-9414-4446-b099-511ed7859417
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
10848530040403
Quantity per Package
50
Contains DI Package
00848530040406
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Corrugated Box
| 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 |