FDA.reportPublic FDA data

Hello Heart Pill Box

Primary DI
00860008267788
Brand
Hello Heart Pill Box
Company
Hello Heart Inc.
Model
HHB02
Device description
Pill Box, AM/PM, Non-TAA, Non-ADA
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
00860008267788PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008267788008600082677888600082677880860008267788

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
00860008267771Hello Heart Pill BoxHHB012026-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860008267771Hello 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
00300021286552Lilly TogetherELI LILLY AND COMPANYNXQ2024-11-26
00860011977513DispenSecurVerinetics IncNXQ2024-08-30