Duns Number:080728314
Device Description: Cellular Modem with Oximetry, Canada
Catalog Number
200601C
Brand Name
DreamStation
Version/Model Number
00
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
OUG
Product Code Name
Medical device data system
Public Device Record Key
0866ebf0-f0d8-4f6e-b708-f8ae8074ca39
Public Version Date
January 06, 2020
Public Version Number
1
DI Record Publish Date
December 29, 2019
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 |