Model: HHB02
DI: 00860008267788
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-06
Current Version: 2026-05-14
Description
Pill Box, AM/PM, Non-TAA, Non-ADA
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
d8496b92-db98-47ec-b7fa-c23c227efadf
Distribution Status:
In Commercial Distribution
DUNS Number:
117407115
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00860008267788
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 62695
Name: Medication adherence telemetric monitoring system, pre-ingestion
Definition:
An 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).
FDA Product Codes
NXQ
Reminder, Medication