Duns Number:080728314
Device Description: DreamStation Wi-Fi Accessory China
Catalog Number
100765W
Brand Name
DreamStation
Version/Model Number
DreamStation Wi-Fi Accessory, CN
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 05, 2021
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
OUG
Product Code Name
Medical device data system
Public Device Record Key
b074024b-bbdd-4135-9de2-3c4b6b58034a
Public Version Date
November 10, 2021
Public Version Number
6
DI Record Publish Date
February 16, 2018
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 | 151 |
2 | A medical device with a moderate to high risk that requires special controls. | 3279 |