Device
This is stand alone software intended for use in the home and clinical settings as an aid for users and their healthcare professionals to view test results which are measured by iH...
Manufacturer
iHealth Labs Inc.
iHealth Labs Inc.
Model: 1.5
DI: 00850044118939
Status: Update
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-05-01
Current Version: 2026-05-12
Description
This is stand alone software intended for use in the home and clinical settings as an aid for users and their healthcare professionals to view test results which are measured by iHealth devices to better manage user's health and get feedback from their professional care team. It can also connect to medical devices and/or non-medical devices and get data from devices during measurement or from the data stored in memory of the device for enhanced data managements. Data can be transmitted, displayed, and stored in the App.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
2
Record Key:
3a6f39a4-782e-44b7-b510-8d51f02c8676
Distribution Status:
In Commercial Distribution
DUNS Number:
054953337
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00850044118939
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 58884
Name: Self-care monitoring/reporting software
Definition:
An application software program designed for the continual collection and aggregation of a patient's self-care data to promote communication between patient and healthcare provider, to facilitate a patient's self-care by using rules defined during use of the application, and/or to facilitate population monitoring. It is typically used to capture clinical (e.g., blood pressure, weight, and blood glucose), nutritional, and/or exercise information in the home, which may include medication administration information captured from enabled injection devices and data from wearable devices, providing care plan, journal, medication advice, and/or messaging functionalities.
FDA Product Codes
MWI
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Premarket Submissions
Submission Number:
K243146
Supplement Number:
000