FDA.reportPublic FDA data

Be Sure

Primary DI
06223015680010
Brand
Be Sure
Company
EPS BIO TECHNOLOGY CORP.
Model
Be Sure
Device description
1 blood glucose meter; 2 AAA(1.5V) Batteries.
Published
2026-05-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
K081796000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081796000EASYPLUS MINI R2N SELF MONITORING GLUCOSE TEST SYSTEMEps Bio Technology Corp.2009-01-23NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16223015680017PackageGS1220Not in Commercial Distribution
06223015680010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1622301568001716223015680017
06223015680010062230156800106223015680010

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.

Regulatory Flags#

DUNS number
658620117
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06225000563827Be StripsBe Strips2026-05-08
06225000563841Be StripsBe Strips2026-05-08
06225000563858Be Smart Blood Glucose MeterBe Smart2026-05-07
06225000563865Be StripsBe Strips2026-05-08
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
00885017000324EasyMax NG Self-Monitoring Blood Glucose SystemEMMU2016-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00860015091611KetoBMKETOBM USA LLCNBW2026-07-14
00860015091628KetoBMKETOBM USA LLCNBW2026-07-14
00860015091635KetoBMKETOBM USA LLCNBW2026-07-14
04719869706904Tyson Bio AC500 PRO Blood Glucose Monitoring System (Meter Only) (FDA)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706911TysonBio AC500 PRO Blood Glucose Test Strips (50T)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706928Tyson Bio AC500 PRO Glucose Control Solution (Level 1 & Level 3)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706942Tyson Bio AC500 PRO Control Solution (Level 1) (FDA)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706959Tyson Bio AC500 PRO Control Solution (Level 3) (FDA)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706973medisana BG 150 Blood Glucose Monitoring SystemTYSON BIORESEARCH INC.NBW2026-07-13
04719869706980medisana BG 150 Blood Glucose Test Strips (50Tx2)TYSON BIORESEARCH INC.NBW2026-07-13
04719869706997medisana BG 150 Control Solution (Level 2)TYSON BIORESEARCH INC.NBW2026-07-13
00860015786869True IntegralTRUE INTEGRAL INCNBW2026-05-27
00860015786876True IntegralTRUE INTEGRAL INCNBW2026-05-27
06225000563827Be StripsEPS BIO TECHNOLOGY CORP.NBW2026-05-08
06225000563841Be StripsEPS BIO TECHNOLOGY CORP.NBW2026-05-08
06225000563865Be StripsEPS BIO TECHNOLOGY CORP.NBW2026-05-08
06225000563858Be Smart Blood Glucose MeterEPS BIO TECHNOLOGY CORP.NBW2026-05-07
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10840330705681TRUE METRIX PROTRIVIDIA HEALTH, INC.NBW2025-10-02
10385540109749CareSens SAgaMatrix, Inc.NBW2025-08-04
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