SENSEONICS, INCORPORATED

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- Catalog Number : FG-5501-01-300

Device Description : Eversense CGM Mobile Application (iOS) is a software application that runs on a Eversense CGM Mobile Application (iOS) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend information, and alerts.

Device Class : 3

Duns Number: 966865636

Premarket Exempt : No

Product Code : QHJ

Prescription Use : Yes

Device Count : 1

- Catalog Number : FG-5502-01-300

Device Description : Eversense CGM Mobile Application (android) is a software application that runs o Eversense CGM Mobile Application (android) is a software application that runs on a mobile device (e.g., smart phone or tablet) and displays glucose data, trend information, and alerts.

Device Class : 3

Duns Number: 966865636

Premarket Exempt : No

Product Code : QHJ

Prescription Use : Yes

Device Count : 1

Device Description : The Eversense Insertion Tools Tray includes the Insertion Tool and the Blunt Dis The Eversense Insertion Tools Tray includes the Insertion Tool and the Blunt Dissector. The tray is a component of the Insertion Tools Kit that is used for Sensor insertion and removal.

Device Class : 3

Duns Number: 966865636

Premarket Exempt : No

Product Code : QHJ, QCD

Prescription Use : Yes

Device Count : 1

Device Description : Eversense Smart Transmitter Kit contains the Eversense Smart Transmitter, chargi Eversense Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, the Eversense CGM User Guide, Eversense CGM Quick Reference Guide and a wallet card.

Device Class : 3

Duns Number: 966865636

Premarket Exempt : No

Product Code : QHJ

Prescription Use : No

Device Count : 1

Device Description : Eversense Sensor Kit contains one Eversense Sensor.

Device Class : 3

Duns Number: 966865636

Premarket Exempt : No

Product Code : QHJ

Prescription Use : Yes

Device Count : 1

Device Description : Eversense adhesive patch is designed to have an adhesive side that attaches to t Eversense adhesive patch is designed to have an adhesive side that attaches to the back of the smart transmitter and a silicone adhesive side that attaches to the skin. The kit contains five 30-packs of white patches and one 30-pack of clear patches.

Device Class : 3

Duns Number: 966865636

Premarket Exempt : No

Product Code : QHJ

Prescription Use : Yes

Device Count : 1

Device Description : Eversense E3 Insertion Tools Kit includes the Insertion Tool, Blunt Dissector, i Eversense E3 Insertion Tools Kit includes the Insertion Tool, Blunt Dissector, incision template and instructions for Sensor insertion and removal.

Device Class : 3

Duns Number: 966865636

Premarket Exempt : No

Product Code : QHJ

Prescription Use : Yes

Device Count : 1

Device Description : Eversense E3 Smart Transmitter Kit contains the Eversense Smart Transmitter, cha Eversense E3 Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, the Eversense E3 CGM User Guide, Eversense E3 CGM Quick Reference Guide, and a wallet card.

Device Class : 3

Duns Number: 966865636

Premarket Exempt : No

Product Code : QHJ

Prescription Use : Yes

Device Count : 1

Device Description : Eversense E3 Smart Transmitter Kit contains the Eversense Smart Transmitter, cha Eversense E3 Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, the Eversense E3 CGM User Guide, Eversense E3 CGM Quick Reference Guide, and a wallet card.

Device Class : 3

Duns Number: 966865636

Premarket Exempt : No

Product Code : QHJ

Prescription Use : Yes

Device Count : 1

Device Description : Eversense E3 Smart Transmitter Kit contains the Eversense Smart Transmitter, cha Eversense E3 Smart Transmitter Kit contains the Eversense Smart Transmitter, charging accessories, the Eversense E3 CGM User Guide, Eversense E3 CGM Quick Reference Guide, and a wallet card.

Device Class : 3

Duns Number: 966865636

Premarket Exempt : No

Product Code : QHJ

Prescription Use : Yes

Device Count : 1