DIGITIVA Mobile Application

FDA UDI

Class I (US FDA UDI)

by Astellas Pharma US, Inc.

Identity

Trade Name: DIGITIVA Mobile Application FDA UDI
Generic Name: Medication reminder application software FDA UDI
Device Name: Software as a Medical Device (SaMD) which operates as a medication reminder and support services; Operates on Apple iOS devices. FDA UDI
Model / Reference: iOS (Version 1) FDA UDI
Description: Software as a Medical Device (SaMD) which operates as a medication reminder and support services; Operates on Apple iOS devices. FDA UDI

Identifiers

Catalog Number: DIGI-001 FDA UDI
Primary DI / UDI-DI: 00304692416089 FDA UDI
FDA Product Code: NXQ FDA UDI
GMDN Term: Medication reminder application software FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 890.5050 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Medication reminder application software

DIGITIVA Mobile Application by Astellas Pharma US, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Lilly Together — ELI LILLY AND COMPANY · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Astellas Pharma US, Inc.

Sources (1)

FDA UDI a16dcdea-4ea7-4c16-a6b5-c8c40f2985ed 35 fields · synced May 31, 2026