FDA.reportPublic FDA data

ReliOn™ Premier Voice Basic Meter

Primary DI
00681131169851
Brand
ReliOn™ Premier Voice Basic Meter
Company
WAL-MART STORES, INC.
Model
780001
Device description
The ReliOn Premier Voice Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh and calf.
Published
2017-11-14
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
CGAGlucose Oxidase, Glucose
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGAGlucose Oxidase, GlucoseClinical Chemistry2
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121133000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121133000CARESENS N VOICE BLOOD GLUCOSE MONITORING SYSTEMI-Sens, Inc.2012-07-10NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10681131169858PackageGS14In Commercial Distribution
00681131169851PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1068113116985810681131169858
00681131169851006811311698516811311698510681131169851

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
Storage Environment Temperature32 Degrees Fahrenheit122 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
1-855-776-0662xxx@xxx.xxx

Regulatory Flags#

DUNS number
051957769
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00194346693122EquateWAL4545V4WAL4545V42026-06-02
00194346693139EquateWAL4245V4WAL4245V42026-06-02
00681131106108Equate5998092362026-02-25
00681131106092Equate5997602702026-02-25
00194346711994ReliOn1943467119942026-05-20
06974021412637equate sitz bathESB-012025-10-08
06974021412644equate shower benchESH-012025-10-08
00194346404131EquateEM47RP2026-05-08
00681131405898EquateHTD8813CHTD8815US2021-04-21
00194346614028Equate 3 UltraUA-8010BLEWMUA-8010BLEWM2026-05-04
00194346618057Equate 1 ProUA-4010WMUA-4010WM2026-05-04
00194346618064Equate 2 PlusUA-6010BLEWMUA-6010BLEWM2026-05-04
00194346404148EquateUHP252026-05-01
00194346404155EquateEM472026-05-01
00681131161602equate6811311616022025-05-14
00681131286213Equate6811312862132020-03-30
00194346067015EQUATE 682710647; 6587876092023-02-14
00681131116374EQUATE682710649, 6513554052022-10-28
00194346699421EquateFBL7100072026-04-17
00194346219230ReliOn™ Premier Classic Meter784001N/A2025-02-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850011135891VALIDATELgc Clinical Diagnostics, Inc.JJX2026-06-02
00630414608273ADVIA Centaur Tumor Marker Quality Control (TM QC)Siemens Healthcare Diagnostics Inc.JJX2026-05-29
00630414622859Atellica IM Tumor Marker Quality Control (TM QC)Siemens Healthcare Diagnostics Inc.JJX2026-05-29
00860015786869True IntegralTRUE INTEGRAL INCNBW2026-05-27
00860015786876True IntegralTRUE INTEGRAL INCNBW2026-05-27
07613336234457PreciControl SyphilisRoche Diagnostics GmbHJJX2026-05-15
08500835120024Diabetes Starter KitOptum Distribution Center, LLCNBW2026-04-21
08058056685407Cystatin C ControlsSENTINEL CH. SPAJJX2025-09-16
00380740153762AlinityABBOTT LABORATORIESJJX2023-10-14
07613336166338PreciControl beta-Amyloid (1-42) IIRoche Diagnostics GmbHJJX2022-12-13
07613336180860CalCheck beta-Amyloid (1-42) IIRoche Diagnostics GmbHJJX2022-12-13
08806128351534metene Blood Glucose Test StripAll Medicus Co.,Ltd.NBW2021-12-24
10050428265106CVS Glucose MeterWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10050428293307CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10050428299118CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
08809115905796Oh'care Lite Smart Glucose Test StripOSANG HEALTHCARE Co., Ltd.NBW2020-11-05
08809115905802Oh'care Lite Smart Glucose MeterOSANG HEALTHCARE Co., Ltd.NBW2020-11-05
08718734960584Eurotrol GlucoTrol-NG Eurotrol B.V.JJX2020-10-08
08718734960607Eurotrol GlucoTrol-NG Eurotrol B.V.JJX2020-10-08
08718734960621Eurotrol AlbuTrolEurotrol B.V.JJX2020-10-08
08718734960645Eurotrol AlbuTrolEurotrol B.V.JJX2020-10-08
08809301161760Pip Blood Glucose Test StripsPHILOSYS Co., LtdCGA2020-09-11
08809301161760Pip Blood Glucose Test StripsPHILOSYS Co., LtdNBW2020-09-11
08809301160862Pip Blood Glucose Monitoring SystemPHILOSYS Co., LtdCGA2020-09-11
10054749005519i-STATABBOTT POINT OF CARE INC.CGA2020-05-01
10096295139553TRUE METRIXTRIVIDIA HEALTH, INC.NBW2020-04-10
10021292014299TRUE METRIXTRIVIDIA HEALTH, INC.NBW2020-03-18
10021292014305TRUE METRIXTRIVIDIA HEALTH, INC.NBW2020-03-18
10021292014312TRUE METRIXTRIVIDIA HEALTH, INC.NBW2020-03-18
10021292014329TRUE METRIXTRIVIDIA HEALTH, INC.NBW2020-03-18