FDA.reportPublic FDA data

EasyMax V Self-Monitoring Blood Glucose System

Primary DI
00885017000058
Brand
EasyMax V Self-Monitoring Blood Glucose System
Company
EPS BIO TECHNOLOGY CORP.
Model
EMV
Device description
one blood glucose meter
Published
2016-09-09
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
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
K092894000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092894000EASYMAX V SELF MONITORING BLOOD GLUCOSE SYSTEMEps Bio Technology Corp.2010-02-24NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
01885017000057PackageGS120In Commercial Distribution
10885017000055PackageGS120In Commercial Distribution
00885017000058PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
01885017000057018850170000571885017000057
1088501700005510885017000055
00885017000058008850170000588850170000580885017000058

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 Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-994-3345info@epsbio.com.tw

Regulatory Flags#

DUNS number
658620117
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06225000563827Be StripsBe Strips2026-05-08
06225000563841Be StripsBe Strips2026-05-08
06225000563865Be StripsBe Strips2026-05-08
06223015680010Be SureBe Sure2026-05-07
06225000563858Be Smart Blood Glucose MeterBe Smart2026-05-07
00885017000171EasyMax 15 Blood Glucose Test StripEM442018-10-12
00885017000010EasyMax Blood Glucose Test StripEasyMax2016-12-12
00885017000355EasyMax Blood Glucose Test StripEasyMax2016-12-12
00885017000447FortisCare Blood Glucose Test StripEM442016-07-24
07506555400010Glucheck Blood Glucose Test StripEM442026-01-02
07506555400003Glucheck Self-Monitoring Blood Glucose SystemEasyMax T1 Pro2026-01-02
27506555400014Glucheck Blood Glucose Test StripEM442026-01-02
00885017000416EasyMax 15 Blood Glucose Test StripEM442016-12-12
00885017000102EasyMax LTC Self-Monitoring Blood Glucose SystemEMMU2018-05-16
0088501700027025 EasyMax FTS Set EN-ESEASY MAX2020-12-10
0088501700028725 EasyMax 15 FTS Set EN-ESEASY MAX 152020-12-10
00885017000553EasyMax NHCS Set ENEasyMax2020-06-23
00885017000560EasyMax 15 NHCS Set ENEM442020-06-23
00885017000638EM 15 Blood Glucose Level 2 Control SolutionEM442019-07-19
00885017000584EM 15 Blood Glucose Level 1 and Level 2 Control SolutionEM442019-07-19

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00860015786876True IntegralTRUE INTEGRAL INCNBW2026-05-27
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30732671309403PipAMITY HOLDINGS, LLCNBW2026-04-16
00856362005159iHealthiHealth Labs Inc.NBW2025-12-19
10612479280486McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2025-12-01
20612479280537McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2025-12-01
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
00850044118236iHealthiHealth Labs Inc.NBW2024-05-28
00850044118243iHealthiHealth Labs Inc.NBW2024-05-27
00010939958617TRUE METRIX AIRTRIVIDIA HEALTH, INC.NBW2023-09-12
00010939958693TRUE METRIXTRIVIDIA HEALTH, INC.NBW2023-09-12
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