XMTR MMT-7703NA UDI RJ BTRY RPL

XMTR MMT
MiniLink® REAL-Time - MMT-7703NA

An assembly of electrically-powered, portable devices intended to continuously monitor interstitial-fluid glucose concentrations in a patient with diabetes mellitus, using an invasive electrochemical technique. It consists of an electrochemical, percutaneously-inserted electrode that physically connects to a cable or transmitter which communicates with a monitor or receiver (not included) that captures, stores, and converts the sensor signals to glucose concentrations for display. The system may be used in the home and clinical settings, and aids in the detection of episodes of hyperglycaemia and hypoglycaemia, facilitating acute/long-term therapy adjustments.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: CGA

Device Name: Glucose Oxidase, Glucose

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 862.1345

Third Party Flag: Y

Medical Specialty: CH

Code: OYC

Device Name: Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

Device Class: 3

Physical State: Must include product code MDS, sensor, invasive test system, or product code PQF, sensor, glucose, invasive, non-adjunctive.

Definition: The insulin pump is intended to be used as a component of an invasive glucose device. The pump is designed to pump fluid (insulin) into a patient in a controlled manner as an aid in the mangement of diabetes mellitus in persons requiring insulin. It is intended to accept and display data from the glucose sensor.

Submission Type ID: 2

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: The pump is designed to pump fluid (insulin) into a patient in a controlled manner as an aid in the mangement of diabetes mellitus in persons requiring insulin. It is intended to accept and display data from the glucose sensor

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: see indications for use

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Code: OZO

Device Name: Automated Insulin Dosing , Threshold Suspend

Device Class: 3

Physical State: May include: Continuous glucose monitoring system, sensor, self monitoring blood glucose device, infusion pump, data management software

Definition: An automated insulin dosing system that temporarily suspends or reduces insulin infusion from an insulin pump based upon specified thresholds of measured glucose levels.

Submission Type ID: 2

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Uses a glucose monitoring system to measure glucose levels in interstitial fluid or blood and suspends or reduces insulin infusion from an insulin pump

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Not meant to act on a specific part of the body but works with other devices - Continuous glucose monitoring system, sensor, self monitoring blood glucose device, data managment software

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Code: MDS

Device Name: Sensor, Glucose, Invasive

Device Class: 3

Physical State: N/A

Definition: The device is a glucose-monitoring device indicated for detecting trends and tracking patterns in adults (age 18 and older) with diabetes. The device is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices. The system aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments.

Submission Type ID: 2

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: 00763000164300

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