Duns Number:118148877
Device Description: A digital epilepsy care management platform application for Android.
Catalog Number
-
Brand Name
Nile
Version/Model Number
Nile for Android
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NXQ
Product Code Name
Reminder, Medication
Public Device Record Key
6026b1aa-304b-40b0-b023-ff47cc66420a
Public Version Date
July 27, 2021
Public Version Number
1
DI Record Publish Date
July 19, 2021
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 | 3 |