FDA.reportPublic FDA data

icompanion

Primary DI
B621ICOMPANION2X2Y0
Brand
icompanion
Company
icometrix NV
Model
2.2
Published
2024-06-07
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
B621ICOMPANION2X2Y0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Self-care monitoring/reporting softwareAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
400793486
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B621ICOBRAINARIA1X2Y0icobrain aria1.22025-10-24
B621ICOBRAINMR5X17Y0icobrain mr5.172025-09-19
B621ICOBRAINARIA1X1Y0icobrain aria1.12025-02-18
B621ICOBRAINCT6X4Y0icobrain ct6.42024-10-11
B621ICOBRAINMR5X16Y0icobrain mr5.162024-08-06
B621ICOBRAINMR5X15Y0icobrain mr5.152024-05-29
B621ICOMPANION2X1Y0icompanion2.12024-02-08
B621ICOBRAINMR5X14Y0icobrain mr5.142023-12-08
B621ICOBRAIN60icobrain62022-06-24
B621ICOBRAINCTP10icobrain ctp12022-06-24
B621ICOBRAIN50icobrain52020-02-17
B621ICOBRAIN40icobrain4.02019-04-08
B621ICOBRAIN20icobrain22018-01-29
B621ICOBRAIN30icobrain32018-03-19
B621ICOMPANION103icompanion12023-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B5531402001OTC0Lilly Health Personalized Medicine and Health PlatformWELLDOC, INC.NXQ2026-07-17
00860008267771Hello Heart Pill BoxHello Heart Inc.NXQ2026-05-06
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