FDA.reportPublic FDA data

BIOCOACH Blood Glucose Test Strips 25s

Primary DI
00850017460065
Brand
BIOCOACH Blood Glucose Test Strips 25s
Company
AMVENTUREX, INC.
Model
S5640988
Catalog number
S5640988
Device description
25s
Published
2021-12-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201880000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201880000MultiSure GK Link Blood Glucose and Ketone Monitoring SystemApex BioTechnology Corp.2021-10-15NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850017460065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850017460065008500174600658500174600650850017460065

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
117225590
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850017460089BIOCOACH Blood Ketone Test Strips 50 Pack (Foil)S5640934S56409342023-05-31
00850017460287BIOCOACH Blood Glucose Test Strips 50 Pack (Foil)S5640936S56409362023-05-31
00850017460027BIOCOACH Blood Glucose Test Strips 50sS5640989S56409892021-12-28
00850017460034BIOCOACH Blood Glucose and Ketone Monitoring SystemS84102S841022021-12-28
00850017460058BIOCOACH Glucose Control Solution L1/L2S5800382S58003822021-12-28
00860060002310KETOCOACH BLOOD KETONE METERs110062019-12-30
00860060002327KETOCOACH 50 BLOOD KETONE TEST STRIPSS56407912019-12-30
00860060002334KETOCOACH CONTROL SOLUTION Level 2S58003352019-12-30
00860060002341KETOCOACH METER ONLYS110072019-12-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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30732671309403PipAMITY HOLDINGS, LLCNBW2026-04-16
10612479280486McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2025-12-01
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30050428284392CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2025-11-30
30050428284484CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2025-11-30
10840330705681TRUE METRIX PROTRIVIDIA HEALTH, INC.NBW2025-10-02
10385540109749CareSens SAgaMatrix, Inc.NBW2025-08-04
00010939958617TRUE METRIX AIRTRIVIDIA HEALTH, INC.NBW2023-09-12
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10612479265513McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2023-05-17
08806128351534metene Blood Glucose Test StripAll Medicus Co.,Ltd.NBW2021-12-24
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
00011822002783TRUE METRIX GOTRIVIDIA HEALTH, INC.NBW2021-08-31
10050428265106CVS Glucose MeterWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10050428293307CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10050428299118CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10888277675681MedlineMEDLINE INDUSTRIES, INC.NBW2020-12-11
10884389831205MedlineMEDLINE INDUSTRIES, INC.NBW2020-11-24
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
08809301161760Pip Blood Glucose Test StripsPHILOSYS Co., LtdNBW2020-09-11
10612479250434MckessonMCKESSON MEDICAL-SURGICAL INC.NBW2020-08-19
10612479250441MckessonMCKESSON MEDICAL-SURGICAL INC.NBW2020-08-19
10612479250458MckessonMCKESSON MEDICAL-SURGICAL INC.NBW2020-08-19