Nile

Basic Information

• Brand Name: Nile
• Primary DI: 00850031821002
• Version / Model: Nile for iOS
• Company Name: Ai Nile Inc
• Labeler DUNS: 118148877
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-19
• Public Version: 1
• Public Version Date: 2021-07-27
• Public Version Status: New
• Public Device Record Key: 29be1c3f-acda-4d99-9bce-405028f857e8

Device Description

A digital epilepsy care management platform application for iOS.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NXQ	Reminder, Medication	Physical Medicine	890.5050	1
OUG	Medical Device Data System	General Hospital	880.6310	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43081	Medication reminder application software	An individual software program or group of programs, routines and/or algorithms, that are used together with a mobile phone (cell phone) or other communication device to function as a medication reminder. It is intended for medical purposes to provide alerts to patients and healthcare providers for predetermined medication dosing schedules. It may also enable the delivery of information about medications, such as indications for use, dosing, side effects, and even photographs of different pills.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850031821002	GS1