SFTWR MMT-6111 CP ANDROID V2.2.0 OUS


Product Overview

SFTWR MMT
CareLink™ Connect - MMT-6111


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 Identifiers

Device Id: 00763000432652

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


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