FDA.reportPublic FDA data

TRUEmanager

Primary DI
00021292008666
Brand
TRUEmanager
Company
TRIVIDIA HEALTH, INC.
Model
TRUEmanager Diabetes Management Software
Catalog number
RM9NPD78
Device description
TRUEmanager Diabetes Management Software
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JQPCalculator/Data Processing Module, For Clinical Use
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JQPCalculator/Data Processing Module, For Clinical UseClinical Chemistry1
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070593000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070593000TRACKRECORD DATA MANAGEMENT SOFTWAREHome Diagnostics, Inc.2007-05-07NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00021292008666PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00021292008666000212920086660212920086660021292008666

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.

Contacts#

Phone, Email table
PhoneEmail
+1(800)803-6032customercare@trividiahealth.com

Regulatory Flags#

DUNS number
151810868
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00050428167243TRUEplusCVS TRUEplus 5-bevel Pen Needle 31G 5mm - 50ct - nS6007B31-502026-10-07
00050428167267TRUEplusTRUEplus 5-bevel Pen Needle 32G 4mmS6007A32-502026-10-07
00050428167281TRUEplusTRUEplus Sterile LancetsS1007DB30-1002026-08-14
00050428167298TRUEdrawCVS TRUEdraw Lancing DeviceS3007-012026-08-14
00050428167304TRUEplusTRUEplus Sterile LancetsS1007LB28-1002026-08-14
00050428167311TRUEplusTRUEplus Sterile LancetsS1007YL33-1002026-08-14
00050428167328TRUEplusTRUEplus Sterile LancetsS1007DB30-2002026-08-14
00050428167380TRUEplusTRUEplus Sterile LancetsS1007YL33-2002026-08-14
00050428324073TRUEplusTRUEplus 5-bevel Pen Needle 32G 4mmS6007A32-1002026-03-17
10050428324070TRUEplusTRUEplus 5-bevel Pen Needle 32G 4mmS6007A32-1002026-03-17
00041260007354TRUE METRIX AIRTRUE METRIX AIR Self Monitoring Blood Glucose MeteREA4203-012026-02-09
10041260007351TRUE METRIX AIRTRUE METRIX AIR Self Monitoring Blood Glucose MeteREA4203-012026-02-09
00021292015381TRUE METRIX PROTRUE METRIX PRO Professional Blood Glucose Monitor2025-12-02
10840330705698TRUE METRIX PROTRUE METRIX PRO Professional Blood Glucose Monitor2025-12-02
00075450843576TRUE METRIX GOTRUE METRIX GO Self-Monitoring Blood Glucose MeterRF4048-012025-11-26
10075450843573TRUE METRIX GOTRUE METRIX GO Self-Monitoring Blood Glucose MeterRF4048-012025-11-26
10840330706541TRUE METRIXTRUE METRIX Control Solution - Level 1 and Level 3R5212-132025-11-25
30840330706545TRUE METRIXTRUE METRIX Control Solution - Level 1 and Level 3R5212-132025-11-25
00021292009120TRUE METRIXTRUE METRIX SELF MONITORING BLOOD GLUCOSE TEST STR2016-09-24
00021292007256TRUE METRIXTRUE METRIX SELF MONITORING BLOOD GLUCOSE METER RE4023-012016-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810142374941SoftBiochemistrySCC SOFT COMPUTERJQP2026-10-16
00810142374958SoftCytogeneticsSCC SOFT COMPUTERJQP2026-10-16
00810142374965SoftPathDxSCC SOFT COMPUTERJQP2026-10-16
00810142374972SoftFlowCytometrySCC SOFT COMPUTERJQP2026-10-16
00810142374989SoftHLASCC SOFT COMPUTERJQP2026-10-16
00810142374996SoftMolecularSCC SOFT COMPUTERJQP2026-10-16
00810142375009SoftGenomicsSCC SOFT COMPUTERJQP2026-10-16
00810142375016SoftTrackSCC SOFT COMPUTERJQP2026-10-16
00810142374071SoftTotalQCSCC SOFT COMPUTERJQP2026-10-07
00810142373456SoftLabSCC SOFT COMPUTERJQP2026-09-29
00810142373463SoftMicSCC SOFT COMPUTERJQP2026-09-29
B236CATL202520Clinisys AtlasCliniSys, IncJQP2026-09-29
00380740225384AlinIQABBOTT SRLJQP2026-09-28
00810142374378SoftBiochemistrySCC SOFT COMPUTERJQP2026-08-26
00810142374385SoftCytogeneticsSCC SOFT COMPUTERJQP2026-08-26
00810142374392SoftPathDxSCC SOFT COMPUTERJQP2026-08-26
00810142374408SoftFlowCytometrySCC SOFT COMPUTERJQP2026-08-26
00810142374415SoftHLASCC SOFT COMPUTERJQP2026-08-26
00810142374422SoftMolecularSCC SOFT COMPUTERJQP2026-08-26
00810142374439SoftGenomicsSCC SOFT COMPUTERJQP2026-08-26
00810142374446SoftTrackSCC SOFT COMPUTERJQP2026-08-26
04719869706966medisana BG 150 Blood Glucose MeterTYSON BIORESEARCH INC.NBW2026-08-19
04719869707000BG 150 Control SolutionTYSON BIORESEARCH INC.NBW2026-08-19
04719869707017BG 150 Control SolutionTYSON BIORESEARCH INC.NBW2026-08-19
04719869707024BG 150 Blood Glucose Test Strip(50T)TYSON BIORESEARCH INC.NBW2026-08-19
00384841518802Prodigy AutoCode Blood Glucose Monitoring SystemProdigy Diabetes Care, LLCNBW2026-08-13
00682607551354ON CALL® SURE BLOOD GLUCOSE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607551361ON CALL® SURE BLOOD GLUCOSE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607551378ON CALL® SURE BLOOD GLUCOSE STRIPSAcon Laboratories, Inc.NBW2026-07-31
00682607815234ON CALL® SURE BLOOD KETONE STRIPSAcon Laboratories, Inc.NBW2026-07-31