DIGITIVA Mobile Application DIGI-002

GUDID 00304692416447

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

Astellas Pharma Us, Inc.

Medication reminder application software

• Primary Device ID: 00304692416447
• NIH Device Record Key: 08cd156f-6aff-43d6-af29-060740b3b2d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIGITIVA Mobile Application
• Version Model Number: Android (Version 1)
• Catalog Number: DIGI-002
• Company DUNS: 605764828
• Company Name: Astellas Pharma Us, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8553486069
• Email: DIGITIVA-support@astellas.com
• Phone: 8553486069
• Email: DIGITIVA-support@astellas.com
• Phone: 8553486069
• Email: DIGITIVA-support@astellas.com
• Phone: 8553486069
• Email: DIGITIVA-support@astellas.com
• Phone: 8553486069
• Email: DIGITIVA-support@astellas.com
• Phone: 8553486069
• Email: DIGITIVA-support@astellas.com
• Phone: 8553486069
• Email: DIGITIVA-support@astellas.com
• Phone: 8553486069
• Email: DIGITIVA-support@astellas.com
• Phone: 8553486069
• Email: DIGITIVA-support@astellas.com
• Phone: 8553486069
• Email: DIGITIVA-support@astellas.com
• Phone: 8553486069
• Email: DIGITIVA-support@astellas.com
• Phone: 8553486069
• Email: DIGITIVA-support@astellas.com
• Phone: 8553486069
• Email: DIGITIVA-support@astellas.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00304692416447 [Primary]

FDA Product Code

• NXQ: Reminder, Medication

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-20
• Device Publish Date: 2025-01-10

On-Brand Devices [DIGITIVA Mobile Application]

• 00304692416089: Software as a Medical Device (SaMD) which operates as a medication reminder and support services
• 00304692416447: Software as a Medical Device (SaMD) which operates as a medication reminder and support services