PRODUCT SOFTWARE MMT
CareLink™ - MMT-7350
Device Description
An application software program, routines, and/or algorithms used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the electronic registration and documentation of patient clinical data. It typically enables healthcare providers to review and update patient medical records, place orders (e.g., for medications, procedures, tests), and sometimes view multimedia data from many specialties. It is supplied for installation into a dedicated information system for patient health records, or existing mainframe or decentralized computers/networks.
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
Device IdentifiersDevice Id: 00763000424138
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