FDA.reportPublic FDA data

Hello Heart Pill Box

Primary DI
00860008267771
Brand
Hello Heart Pill Box
Company
Hello Heart Inc.
Model
HHB01
Device description
Pill Box, Daily, Non ADA, Non TAA
Published
2026-05-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00860008267771PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008267771008600082677718600082677710860008267771

GMDN Terms#

Term, Definition table
TermDefinition
Medication adherence telemetric monitoring system, pre-ingestionAn electronic device intended to be used to facilitate medication adherence by a patient who is self-managing oral medication by monitoring medication retrieval (before ingestion), and generating alerts to the patient and caregivers when errors in retrieval of scheduled dosages are detected. It is a programmable electronic unit, in which the medication dosages are loaded, with built-in sensors that detect the missed/incorrect removal of individual dosages; it generates local audiovisual reminders/alarms to warn the patient, and is able to telecommunicate data via a mobile network to report medication adherence to caregivers (e.g., via an on-line portal, or phone texts).

Regulatory Flags#

DUNS number
117407115
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860008267788Hello Heart Pill BoxHHB022026-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B5531401001OTC0Lilly Health Personalized Medicine and Health PlatformWELLDOC, INC.NXQ2026-07-17
B5531402001OTC0Lilly Health Personalized Medicine and Health PlatformWELLDOC, INC.NXQ2026-07-17
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
00304692416447DIGITIVA Mobile ApplicationAstellas Pharma Us, Inc.NXQ2025-01-10
05419980275011Neuroventis PlatformNeuroventisNXQ2025-01-01
00304692416089DIGITIVA Mobile ApplicationAstellas Pharma Us, Inc.NXQ2024-12-12
00300021285555Lilly TogetherELI LILLY AND COMPANYNXQ2024-11-26