FDA.reportPublic FDA data

TRUE METRIX

Primary DI
00021292009120
Brand
TRUE METRIX
Company
TRIVIDIA HEALTH, INC.
Model
TRUE METRIX SELF MONITORING BLOOD GLUCOSE TEST STR
Device description
TRUE METRIX SELF MONITORING BLOOD GLUCOSE TEST STRIPS - 30 Test Strips
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LFRGlucose Dehydrogenase, Glucose
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFRGlucose Dehydrogenase, GlucoseClinical Chemistry2
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00010939802446PackageGS11Not in Commercial Distribution
00010939958723PackageGS11In Commercial Distribution
00011822002776PackageGS11In Commercial Distribution
00021292008925PackageGS11Not in Commercial Distribution
00021292009083PackageGS11In Commercial Distribution
00021292012441PackageGS12In Commercial Distribution
00021292015268PackageGS11In Commercial Distribution
00036800234512PackageGS11In Commercial Distribution
00041220047581PackageGS11In Commercial Distribution
00041260016035PackageGS11In Commercial Distribution
00041415097780PackageGS11In Commercial Distribution
00050428498910PackageGS12In Commercial Distribution
00050428594537PackageGS11In Commercial Distribution
00052569140116PackageGS11Not in Commercial Distribution
00075450824445PackageGS11In Commercial Distribution
00087701427602PackageGS11In Commercial Distribution
00087701434723PackageGS11In Commercial Distribution
00096295142044PackageGS11In Commercial Distribution
00311917033006PackageGS12In Commercial Distribution
00311917207636PackageGS11In Commercial Distribution
00321130788638PackageGS11In Commercial Distribution
00713733297073PackageGS12In Commercial Distribution
00713733405256PackageGS11In Commercial Distribution
10010939802443PackageGS124Not in Commercial Distribution
10010939958720PackageGS124In Commercial Distribution
10011822002773PackageGS112In Commercial Distribution
10021292008922PackageGS124Not in Commercial Distribution
10021292009080PackageGS124In Commercial Distribution
10021292012448PackageGS112In Commercial Distribution
10021292015265PackageGS124In Commercial Distribution
10036800234519PackageGS124In Commercial Distribution
10041220047588PackageGS124In Commercial Distribution
10041260016032PackageGS124In Commercial Distribution
10041415097787PackageGS124In Commercial Distribution
10050428498917PackageGS112In Commercial Distribution
10050428594534PackageGS124In Commercial Distribution
10052569140113PackageGS124Not in Commercial Distribution
10075450824442PackageGS124In Commercial Distribution
10087701427609PackageGS124In Commercial Distribution
10087701434720PackageGS112In Commercial Distribution
10311917033003PackageGS112In Commercial Distribution
10311917207633PackageGS124In Commercial Distribution
10321130788635PackageGS124In Commercial Distribution
10713733297070PackageGS112In Commercial Distribution
10713733405253PackageGS112In Commercial Distribution
50096295142049PackageGS124In Commercial Distribution
00021292009120PrimaryGS10
00021292007799Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00010939802446000109398024460109398024460010939802446
00010939958723000109399587230109399587230010939958723
00011822002776000118220027760118220027760011822002776
00021292008925000212920089250212920089250021292008925
00021292009083000212920090830212920090830021292009083
00021292012441000212920124410212920124410021292012441
00021292015268000212920152680212920152680021292015268
00036800234512000368002345120368002345120036800234512
00041220047581000412200475810412200475810041220047581
00041260016035000412600160350412600160350041260016035
00041415097780000414150977800414150977800041415097780
00050428498910000504284989100504284989100050428498910
00050428594537000504285945370504285945370050428594537
00052569140116000525691401160525691401160052569140116
00075450824445000754508244450754508244450075450824445
00087701427602000877014276020877014276020087701427602
00087701434723000877014347230877014347230087701434723
00096295142044000962951420440962951420440096295142044
00311917033006003119170330063119170330060311917033006
00311917207636003119172076363119172076360311917207636
00321130788638003211307886383211307886380321130788638
00713733297073007137332970737137332970730713733297073
00713733405256007137334052567137334052560713733405256
1001093980244310010939802443
1001093995872010010939958720
1001182200277310011822002773
1002129200892210021292008922
1002129200908010021292009080
1002129201244810021292012448
1002129201526510021292015265
1003680023451910036800234519
1004122004758810041220047588
1004126001603210041260016032
1004141509778710041415097787
1005042849891710050428498917
1005042859453410050428594534
1005256914011310052569140113
1007545082444210075450824442
1008770142760910087701427609
1008770143472010087701434720
1031191703300310311917033003
1031191720763310311917207633
1032113078863510321130788635
1071373329707010713733297070
1071373340525310713733405253
5009629514204950096295142049
00021292009120000212920091200212920091200021292009120
00021292007799000212920077990212920077990021292007799

GMDN Terms#

Term, Definition table
TermDefinition
Glucose monitoring system IVD, home-useA collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature40 Degrees Fahrenheit86 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1(800)803-6025customercare@trividiahealth.com

Regulatory Flags#

DUNS number
151810868
Device count
30
Lot or batch
true
Expiration date on label
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
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
00021292012823SidekickSidekick All-In-One Blood Glucose Monitoring SysteD4H01-832018-09-21

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