FDA.reportPublic FDA data

Center Health PHV

Primary DI
00860003222331
Brand
Center Health PHV
Company
CENTER HEALTH INCORPORATED
Model
5.43.39
Published
2026-06-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
00860003222331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003222331008600032223318600032223310860003222331

GMDN Terms#

Term, Definition table
TermDefinition
Self-care monitoring/reporting softwareAn application software program designed for the continual collection and aggregation of a patient's self-care data to promote communication between patient and healthcare provider, to facilitate a patient's self-care by using rules defined during use of the application, and/or to facilitate population monitoring. It is typically used to capture clinical (e.g., blood pressure, weight, and blood glucose), nutritional, and/or exercise information in the home, which may include medication administration information captured from enabled injection devices and data from wearable devices, providing care plan, journal, medication advice, and/or messaging functionalities.

Regulatory Flags#

DUNS number
080946441
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860003222300Center Health Nano Smart Dongle Blood Glucose Monitoring SystemTD-41402020-03-17
00860003222317Center Health Blood Glucose Test Strips (50pcs/bot)TD-41402020-03-17
00860003222324Center Health Smart Lightning dongle Blood Glucose Monitoring SystemTD-41402020-03-17
04710469871498Center Health Blood Glucose Monitoring SystemTD-41402019-10-01
04713106027173Center Health Nano Smart Dongle Blood Glucose MoniTD-41402019-01-28
04713106027180Center Health Blood Glucose Test Strips (50pcs/botTD-41402019-01-28

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