FDA.reportPublic FDA data

GlucoLeader Enhance Blood Glucose foil packed test strip

Primary DI
04711200721843
Brand
GlucoLeader Enhance Blood Glucose foil packed test strip
Company
HMD BIOMEDICAL INC.
Model
3L-10-14003T
Catalog number
3L-10-14003T
Device description
GlucoLeader Enhance GL Blood Glucose foil packed test strip
Published
2021-01-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
CGAGlucose Oxidase, Glucose
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGAGlucose Oxidase, GlucoseClinical Chemistry2
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032985000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032985000GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEMHmd Biomedical, Inc.2003-10-21NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04711200723076PackageGS1240In Commercial Distribution
04711200721843PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04711200723076047112007230764711200723076
04711200721843047112007218434711200721843

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
658644174
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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04711200724837GL GoodLife 001 Blood Glucose Test Strip3S-01-25003T3S-01-25003T2026-05-08
04711200724844GL GoodLife 001 Glucose Control Solution3C-01-2500373C-01-2500372026-05-08
00389154000266GL GoodLife Blood Glucose Test Strip-Foil For CloudiaIG STRIP FOIL3L-10-8100372017-11-14
00389154000594GL GoodLife Blood Glucose Test StripAC-11 AC302 (vial)3S-01-16003E2016-12-09
00810038634869Easy@Home Blood Glucose Test Strip3S-01-2500383S-01-2500382023-03-15
00810038636061Easy@Home EBG-100BLE blood glucose monitoring system3K-01-25003G3K-01-25003G2024-07-17
00810038636894Easy@Home EBG-100BLE Blood Glucose Test Strip3S-01-25003F3S-01-25003F2024-07-17
00850048540491LPOW blood glucose monitoring system(Meter)3K-01-25003E3K-01-25003E2023-09-28
00850048540507LPOW Blood Glucose Test Strip3S-01-25003E3S-01-25003E2023-09-28
00868665000052Rosie SmartMeter Professional StripAC-11 Pro-Strip3L-10-16003E2016-12-07
04260236850244FIA Salut CS063K-01-14003163K-01-14003162020-07-06
04260236850329PRECICHEK AutoCode foil packed test strip3L-10-1600313L-10-1600312020-07-01
04260236850367FIA Salut foil packed test strip3L-10-1400333L-10-1400332020-07-08
04260236850411PRECICHEK AutoCode vial packed test Strip3S-01-1600323S-01-1600322020-05-12
04260236850459FIA Salut foil packed test strip(for SS)3L-10-14003A3L-10-14003A2020-07-17
04260236850466FIA Salut vial packed test strip3S-01-14003353S-01-14003352020-07-06
04260236850480FIA Salut vial packed test strip3S-01-14003343S-01-14003342020-07-08
04260236850619PRECICHEK AutoCode AC3023K-01-16003A3K-01-16003A2020-07-06
04260236850664PRECICHEK AutoCode foil packed test strip3L-10-16003D3L-10-16003D2020-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10612479280486McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2025-12-01
10840330705681TRUE METRIX PROTRIVIDIA HEALTH, INC.NBW2025-10-02
10385540109749CareSens SAgaMatrix, Inc.NBW2025-08-04
10612479265513McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2023-05-17
10385480631645Nova PrimaryNOVA BIOMEDICAL CORPORATIONCGA2023-02-24
10385480631652Nova PrimaryNOVA BIOMEDICAL CORPORATIONCGA2023-02-24
10385480631669Nova Primary NOVA BIOMEDICAL CORPORATIONCGA2023-02-24
10385480632307Nova PrimaryNOVA BIOMEDICAL CORPORATIONCGA2023-02-22
10673486000719TECO DIAGNOSTICSTECO DIAGNOSTICSCGA2022-08-09
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10760236150357Meijer Essential Blood Glucose MeterMEIJER, INC.NBW2021-11-05
10760236150364Meijer Essential Wireless Blood Glucose MeterMEIJER, INC.NBW2021-11-05
10760236150371Meijer Essential Blood Glucose Test StripsMEIJER, INC.NBW2021-11-05
10888277365940MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.NBW2021-10-01
10050428265106CVS Glucose MeterWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10050428293307CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10050428299118CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10888277409187MedlineMEDLINE INDUSTRIES, INC.CGA2020-12-11
10888277675681MedlineMEDLINE INDUSTRIES, INC.NBW2020-12-11
10888277409170MedlineMEDLINE INDUSTRIES, INC.CGA2020-12-10
10884389831205MedlineMEDLINE INDUSTRIES, INC.NBW2020-11-24
08809115905796Oh'care Lite Smart Glucose Test StripOSANG HEALTHCARE Co., Ltd.NBW2020-11-05
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08809301161760Pip Blood Glucose Test StripsPHILOSYS Co., LtdNBW2020-09-11
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10612479250434MckessonMCKESSON MEDICAL-SURGICAL INC.NBW2020-08-19