icompanion

Basic Information

• Brand Name: icompanion
• Primary DI: B621ICOMPANION103
• Version / Model: 1
• Company Name: icometrix NV
• Labeler DUNS: 400793486
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-22
• Public Version: 3
• Public Version Date: 2023-11-27
• Public Version Status: Update
• Public Device Record Key: 2b7f5241-d438-43c9-80c8-3c4466ac1fa1

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NXQ	Reminder, Medication	Physical Medicine	890.5050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58884	Self-care monitoring/reporting software	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B621ICOMPANION103	HIBCC