AccessGUDID - DEVICE: DIGITIVA Mobile Application (00304692416089)

GUDID

Device Identifier (DI) Information

Brand Name: DIGITIVA Mobile Application
Version or Model: iOS (Version 1)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DIGI-001
Company Name: Astellas Pharma Us, Inc.

Primary DI Number: 00304692416089
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 605764828 *Terms of Use

Device Description: Software as a Medical Device (SaMD) which operates as a medication reminder and support services; Operates on Apple iOS devices.

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

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: a16dcdea-4ea7-4c16-a6b5-c8c40f2985ed
Public Version Date: December 20, 2024
Public Version Number: 1
DI Record Publish Date: December 12, 2024