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
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
00021292007843TRUE METRIXTRUE METRIX SELF MONITORING BLOOD GLUCOSE TEST STRR3NPD03, RF3TVH702016-09-20
00021292007874TRUE METRIX PROTRUE METRIX PRO BLOOD GLUCOSE TEST STRIPS - 10 Tes2016-09-20
00021292012236TRUE METRIXTRUE METRIX Self Monitoring Blood Glucose Test Str2018-02-01
00021292012779TRUEplusTRUEplus 3-Bevel Pen Needle 29G/12mm - 100ct boxS5H01F29-100TC2019-02-20
00021292012786TRUEplusTRUEplus 3-Bevel Pen Needle 31G/5mm - 100ct boxS5H01B31-100TC2019-02-20
00021292012793TRUEplusTRUEplus 3-Bevel Pen Needle 31G/6mm - 100ct boxS5H01C31-100TC2019-02-20
00021292012809TRUEplusTRUEplus 3-Bevel Pen Needle 31G/8mm - 100ct boxS5H01D31-100TC2019-02-20
00021292012816TRUEplusTRUEplus 3-Bevel Pen Needle 32G/4mm - 100ct boxS5H01A32-100TC2019-02-20

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810142374507SoftMolecularSCC SOFT COMPUTERJQP2026-07-14
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00810142374521SoftTrackSCC SOFT COMPUTERJQP2026-07-14
00850078377265iHealthiHealth Labs Inc.NBW2026-07-14
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00860015091611KetoBMKETOBM USA LLCNBW2026-07-14
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04719869706928Tyson Bio AC500 PRO Glucose Control Solution (Level 1 & Level 3)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706942Tyson Bio AC500 PRO Control Solution (Level 1) (FDA)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706959Tyson Bio AC500 PRO Control Solution (Level 3) (FDA)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706973medisana BG 150 Blood Glucose Monitoring SystemTYSON BIORESEARCH INC.NBW2026-07-13
04719869706980medisana BG 150 Blood Glucose Test Strips (50Tx2)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706997medisana BG 150 Control Solution (Level 2)TYSON BIORESEARCH INC.NBW2026-07-13
00810142374279SoftBiobankSCC SOFT COMPUTERJQP2026-07-07
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00810142373883SoftPathDxSCC SOFT COMPUTERJQP2026-06-10
00810142373890SoftFlowCytometrySCC SOFT COMPUTERJQP2026-06-10
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00810142373920SoftMolecularSCC SOFT COMPUTERJQP2026-06-10