Dexcom Portrait on the Web 350-0010

GUDID B059POW3500010

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

SWEETSPOT DIABETES CARE, INC.

Noninvasive interstitial-fluid glucose monitoring system
Primary Device IDB059POW3500010
NIH Device Record Keyb9fea405-cc6b-4bdd-bd52-7d073f185048
Commercial Distribution Discontinuation2016-12-30
Commercial Distribution StatusNot in Commercial Distribution
Brand NameDexcom Portrait on the Web
Version Model Number350-0010
Catalog Number350-0010
Company DUNS963889204
Company NameSWEETSPOT DIABETES CARE, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB059POW3500010 [Primary]

FDA Product Code

PHVContinuous Glucose Monitor Retrospective Data Analysis Software

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-08-26

Devices Manufactured by SWEETSPOT DIABETES CARE, INC.

B059CLARITY35000011 - Dexcom CLARITY2018-03-29 Dexcom CLARITY software, web-based data management product is intended for use by both patients and healthcare professionals to
B059DMS3500003 - DATA MANAGEMENT SYSTEM2018-03-29 Software-as-a-Service Diabetes Data Management Service. System extracts information from BGMs and formats reports of the blood
B059POW3500010 - Dexcom Portrait on the Web2018-03-29Data management reporting software use for Dexcom Continuous Glucose Monitoring devices.
B059POW3500010 - Dexcom Portrait on the Web2018-03-29 Data management reporting software use for Dexcom Continuous Glucose Monitoring devices.

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