Sensor, Glucose, Invasive, Non-Adjunctive

FDA Pre-Market Approval

FDA Class 3 ·Simplera™ System

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Paradigm Real-Time Revel System

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 530G System

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 630G System with SmartGuard

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Guardian Connect System

CGM TELEMEDICINE S.R.L.

Authorized representative

🇮🇹 Italy

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·ENLITE SENSOR

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·SOF-SENSOR

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Pre-Market Approval

FDA Class 3 ·ANIMAS VIBE SYSTEM

Anesthesia Conduction Kit

FDA classification

FDA Class 2 ·Anesthesia Conduction Kit

Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling

FDA classification

FDA Class 2 ·Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling

Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

FDA Pre-Market Approval

FDA Class 3 ·Freestyle Libre Flash Glucose Monitoring System

Portex

FDA UDI

Smiths Medical ASD, Inc.·15019517078787·

PROLONG* Continuous Nerve Block Set

FDA UDI

Avanos Medical, Inc.·00193494327767·PROLONG* Continuous Nerve Block Set

Portex

FDA UDI

Smiths Medical ASD, Inc.·15019517071368·

PROLONG* Continuous Nerve Block Set with NRFit™ Connector

FDA UDI

Avanos Medical, Inc.·00193494452247·EchoBright* Needles

Portex

FDA UDI

Smiths Medical ASD, Inc.·15019517078619·

PROLONG* Continuous Nerve Block Set

FDA UDI

Avanos Medical, Inc.·00193494386047·PROLONG* Continuous Nerve Block Set

Portex

FDA UDI

Smiths Medical ASD, Inc.·15019517071382·