SFTWR MMT
CareLink™ Connect - MMT-6112
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: 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: 00763000437787
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