SFTWR MMT
Sugar.IQ™ - MMT-8100
Device Description
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.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: PHV
Device Name: Continuous Glucose Monitor Retrospective Data Analysis Software
Device Class: 1
Physical State: Software
Definition: Continuous glucose monitor retrospective data analysis software is intended to analyze and correlate retrospective data from a continuous glucose monitoring device.
Submission Type ID: 4
Review Panel: CH
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: data analysis system
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: Not Applicable
Regulation Number: 862.2120
Third Party Flag: N
Medical Specialty: CH
Code: PKU
Device Name: Insulin Pump Secondary Display
Device Class: 2
Physical State: Typically a software device installed on a third-party mobile device, or implemented in a web-based platform.
Definition: The purpose of the insulin pump secondary display is to notify another person of the patient's insulin pump usage information in real time. The secondary display is intended for providing secondary notification of insulin pump usage and does not replace primary real time insulin pump monitoring or standard home blood glucose monitoring.
Submission Type ID: 4
Review Panel: CH
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Receives and displays real-time patient data from an insulin pump.
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: n/a
Regulation Number: 862.1350
Third Party Flag: N
Medical Specialty: CH
Device IdentifiersDevice Id: 00763000086619
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A