Duns Number:141668116
Device Description: Sunset Healthcare Solutions Replacement Deluxe Nasal Pillows - Size Large. Fits with Delu Sunset Healthcare Solutions Replacement Deluxe Nasal Pillows - Size Large. Fits with Deluxe Nasal Pillow CPAP Mask Item #CM036
Catalog Number
CM036LP
Brand Name
Replacement Deluxe Nasal Pillows - Large
Version/Model Number
CM036LP
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
-
Product Code
BZD
Product Code Name
Ventilator, Non-Continuous (Respirator)
Public Device Record Key
b0a923b8-a27c-484b-9d08-35ccff02062a
Public Version Date
June 19, 2018
Public Version Number
3
DI Record Publish Date
March 01, 2017
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 |