FDA.reportPublic FDA data

DIGITIVA Mobile Application

Primary DI
00304692416447
Brand
DIGITIVA Mobile Application
Company
Astellas Pharma Us, Inc.
Model
Android (Version 1)
Catalog number
DIGI-002
Device description
Software as a Medical Device (SaMD) which operates as a medication reminder and support services; Operates on Android devices.
Published
2025-01-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
NXQReminder, Medication

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NXQReminder, MedicationPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00304692416447PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00304692416447003046924164473046924164470304692416447

GMDN Terms#

Term, Definition table
TermDefinition
Medication reminder application softwareAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8553486069DIGITIVA-support@astellas.com

Regulatory Flags#

DUNS number
605764828
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00304692416089DIGITIVA Mobile ApplicationiOS (Version 1)DIGI-0012024-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860008267771Hello Heart Pill BoxHello Heart Inc.NXQ2026-05-06
00860008267788Hello Heart Pill BoxHello Heart Inc.NXQ2026-05-06
B553202211OTC0Lilly Health Personalized Medicine and Health PlatformWELLDOC, INC.NXQ2026-04-21
B553202212OTC0Lilly Health Personalized Medicine and Health PlatformWELLDOC, INC.NXQ2026-04-21
B553202294OTC0Health Optimizer for Rare Condition MembersWELLDOC, INC.NXQ2026-03-30
B553202295OTC0Health Optimizer for Rare Condition MembersWELLDOC, INC.NXQ2026-03-30
B553202311OTC0WelldocWELLDOC, INC.NXQ2026-03-09
B553202312OTC0WelldocWELLDOC, INC.NXQ2026-03-09
B553202313OTC0WelldocWELLDOC, INC.NXQ2026-03-09
07350149360033PD Care SystemPainDrainer ABNXQ2026-03-04
00854073007110VIVI CAP SMART CoverTempramedNXQ2026-03-01
00086001518102iTonic MediTrust Automated Medication Management SystemGERI-SAFE, LTD.NXQ2026-02-05
00854073007103VIVI CAP SMARTTempramedNXQ2025-12-09
07350149360026PD Care SystemPainDrainer ABNXQ2025-11-13
B553202301OTC0WelldocWELLDOC, INC.NXQ2025-07-21
B553202302OTC0WelldocWELLDOC, INC.NXQ2025-07-21
B553202303OTC0WelldocWELLDOC, INC.NXQ2025-07-21
B553202201OTC0Lilly Health Personalized Medicine and Health PlatformWELLDOC, INC.NXQ2025-06-03
B553202202OTC0Lilly Health Personalized Medicine and Health PlatformWELLDOC, INC.NXQ2025-05-28
00300021451554Lilly TogetherELI LILLY AND COMPANYNXQ2025-04-17
00300021458553Lilly TogetherELI LILLY AND COMPANYNXQ2025-04-17
B553202161OTC0MDLIVE Health CoachingWELLDOC, INC.NXQ2025-04-11
B553202162OTC0MDLIVE Health CoachingWELLDOC, INC.NXQ2025-04-11
B553202194OTC0Health Optimizer for Rare Condition MembersWELLDOC, INC.NXQ2025-04-11
B553202195OTC0Health Optimizer for Rare Condition MembersWELLDOC, INC.NXQ2025-04-11
05419980275011Neuroventis PlatformNeuroventisNXQ2025-01-01
00304692416089DIGITIVA Mobile ApplicationAstellas Pharma Us, Inc.NXQ2024-12-12
00300021285555Lilly TogetherELI LILLY AND COMPANYNXQ2024-11-26
00300021286552Lilly TogetherELI LILLY AND COMPANYNXQ2024-11-26
00860011977513DispenSecurVerinetics IncNXQ2024-08-30