AccessGUDID - DEVICE: Nile HCP (00850031821026)

GUDID

Device Identifier (DI) Information

Brand Name: Nile HCP
Version or Model: Nile for HCPs
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Ai Nile Inc

Primary DI Number: 00850031821026
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118148877 *Terms of Use

Device Description: A digital epilepsy care management web portal for HCP.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NXQ	Reminder, Medication
OUG	Medical Device Data System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c398706b-e8ef-4075-b36b-75ce2325b444
Public Version Date: July 27, 2021
Public Version Number: 1
DI Record Publish Date: July 19, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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