DIGITIVA Mobile Application DIGI-001

GUDID 00304692416089

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

Astellas Pharma Us, Inc.

Medication reminder application software
Primary Device ID00304692416089
NIH Device Record Keya16dcdea-4ea7-4c16-a6b5-c8c40f2985ed
Commercial Distribution StatusIn Commercial Distribution
Brand NameDIGITIVA Mobile Application
Version Model NumberiOS (Version 1)
Catalog NumberDIGI-001
Company DUNS605764828
Company NameAstellas Pharma Us, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8553486069
EmailDIGITIVA-support@astellas.com
Phone8553486069
EmailDIGITIVA-support@astellas.com
Phone8553486069
EmailDIGITIVA-support@astellas.com
Phone8553486069
EmailDIGITIVA-support@astellas.com
Phone8553486069
EmailDIGITIVA-support@astellas.com
Phone8553486069
EmailDIGITIVA-support@astellas.com
Phone8553486069
EmailDIGITIVA-support@astellas.com
Phone8553486069
EmailDIGITIVA-support@astellas.com
Phone8553486069
EmailDIGITIVA-support@astellas.com
Phone8553486069
EmailDIGITIVA-support@astellas.com
Phone8553486069
EmailDIGITIVA-support@astellas.com
Phone8553486069
EmailDIGITIVA-support@astellas.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100304692416089 [Primary]

FDA Product Code

NXQReminder, Medication

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-20
Device Publish Date2024-12-12

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