Duns Number:141668116
Device Description: Sunset Healthcare Solutions Replacement Deluxe Nasal Pillows - Size Small. Fits with Delu Sunset Healthcare Solutions Replacement Deluxe Nasal Pillows - Size Small. Fits with Deluxe Nasal Pillow CPAP Mask Item #CM036
Catalog Number
CM036SP
Brand Name
Replacement Deluxe Nasal Pillows - Small
Version/Model Number
CM036SP
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
86a89c74-6cf2-4f11-91c4-1806f019540f
Public Version Date
October 01, 2018
Public Version Number
4
DI Record Publish Date
March 01, 2017
Package DI Number
10848530085879
Quantity per Package
100
Contains DI Package
00848530085872
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 |