SWEETSPOT DIABETES CARE, INC.

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Continuous Glucose Monitor Retrospective Data Analysis Software (PHV) (2) System, Test, Blood Glucose, Over The Counter (NBW) (1)

Premarket Exempt

No Yes

Clear

Dexcom CLARITY - B059CLARITY35000011 Catalog Number : 350-0011

Device Description : Dexcom CLARITY software, web-based data management product is intendedfor use by Dexcom CLARITY software, web-based data management product is intendedfor use by both patients and healthcare professionals to assist people with diabetes in thereview, analysis and evaluation of historical CGM data to support effective diabetesmanagement. It is intended for use as an accessory to CGM devices with data interfacecapabilities.With RCP, it provides additional administrative features for use by Clinicians toaccess Dexcom CLARITY reports (digital or print) for their patients with diabetes. Thesefeatures do not change the intended use of CLARITY. They improve the usefulness of it fromthe clinician perspective.

Device Class : 1

Duns Number: 963889204

Premarket Exempt : Yes

Product Code : PHV

Prescription Use : No

Device Count : 1

DATA MANAGEMENT SYSTEM - B059DMS3500003 Catalog Number : SSDMS

Device Description : Software-as-a-Service Diabetes Data Management Service. System extracts informa Software-as-a-Service Diabetes Data Management Service. System extracts information from BGMs and formats reports of the blood glucose data.

Device Class : 2

Duns Number: 963889204

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

Dexcom Portrait on the Web - B059POW3500010 Catalog Number : 350-0010

Device Description : Data management reporting software use for Dexcom Continuous Glucose Monitoring devices.

Device Class : 1

Duns Number: 963889204

Premarket Exempt : No

Product Code : PHV

Prescription Use : No

Device Count : 1

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