FDA.reportPublic FDA data

Dexcom Portrait on the Web

Primary DI
B059POW3500010
Brand
Dexcom Portrait on the Web
Company
SWEETSPOT DIABETES CARE, INC.
Model
350-0010
Catalog number
350-0010
Device description
Data management reporting software use for Dexcom Continuous Glucose Monitoring devices.
Published
2016-08-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
PHVContinuous Glucose Monitor Retrospective Data Analysis Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PHVContinuous Glucose Monitor Retrospective Data Analysis SoftwareClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B059POW3500010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive interstitial-fluid glucose monitoring systemAn assembly of portable electronic battery-powered devices designed to continuously measure and record interstitial-fluid glucose concentrations, typically for detecting trends and tracking patterns in a patient with diabetes mellitus, using a noninvasive technique. It includes a monitor with optical sensor that measures interstitial glucose concentrations using Raman spectroscopy, and a display which can be a dedicated electronic device or a software application that runs on portable electronics (e.g., smartphone). It may be used in the home or clinical setting, and aids in the detection of episodes of hyperglycaemia and hypoglycaemia, facilitating acute/long-term therapy adjustments.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
963889204
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B059CLARITY35000011Dexcom CLARITY350-0011350-00112016-08-26
B059DMS3500003DATA MANAGEMENT SYSTEM350-0003SSDMS2016-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B553202311OTC0WelldocWELLDOC, INC.PHV2026-03-09
B553202312OTC0WelldocWELLDOC, INC.PHV2026-03-09
B553202313OTC0WelldocWELLDOC, INC.PHV2026-03-09
B553202406OTC0Welldoc Rx App for Diabetes in Pregnancy and Insulin Pump UsersWELLDOC, INC.PHV2025-12-09
10385083000152Omnipod Discover Insulet CorporationPHV2025-12-04
B553202301OTC0WelldocWELLDOC, INC.PHV2025-07-21
B553202302OTC0WelldocWELLDOC, INC.PHV2025-07-21
B553202303OTC0WelldocWELLDOC, INC.PHV2025-07-21
B553202257OTC0Welldoc App for Diabetes in Pregnancy and Insulin Pump UsersWELLDOC, INC.PHV2025-05-29
00763000984755CareLink™ PersonalMEDTRONIC MINIMED, INC.PHV2025-01-02
00763000984762CareLink™ ClinicMEDTRONIC MINIMED, INC.PHV2025-01-02
B553202057OTC0Welldoc App for Diabetes in Pregnancy and Insulin Pump UsersWELLDOC, INC.PHV2024-12-27
00850018992435Sugarmate, iOS Mobile ApplicationSugarmate, LLCPHV2023-09-06
00850018992602Sugarmate, Mac Glance ApplicationSugarmate, LLCPHV2023-09-06
00850018992619Sugarmate, Web ApplicationSugarmate, LLCPHV2023-09-06
00850018992626Sugarmate, Alexa Skill ApplicationSugarmate, LLCPHV2023-09-06
00850003506517Bigfoot Unity ReportBigfoot Biomedical, Inc.PHV2023-07-12
00389152106113Tandem SourceTandem Diabetes Care, Inc.PHV2023-06-20
07290017735023endo.digitalDREAMED DIABETES LTDPHV2022-09-20
00817491023506Eversense DMSSENSEONICS, INCORPORATEDPHV2022-03-10
00817491023513Eversense DMS ProSENSEONICS, INCORPORATEDPHV2022-03-10
00357599826000LibreView GovernmentABBOTT DIABETES CARE INCPHV2021-07-15
00357599823009LibreViewABBOTT DIABETES CARE INCPHV2021-05-21
00763000424121CareLink™ PersonalMEDTRONIC MINIMED, INC.PHV2021-03-07
00763000424138CareLink™MEDTRONIC MINIMED, INC.PHV2021-03-07
00855093008033Glooko Mobile ApplicationGLOOKO, INC.PHV2021-02-16
00855093008040Cornerstones4Care® Powered by Glooko Mobile ApplicationGLOOKO, INC.PHV2021-02-16
00855093008026Glooko Web ApplicationGLOOKO, INC.PHV2021-02-16
00860000249515Onduo VERILY LIFE SCIENCES LLCPHV2020-08-25
00860000249522OnduoVERILY LIFE SCIENCES LLCPHV2020-08-25