FDA.reportPublic FDA data

Dario Blood Glucose Monitoring System

Primary DI
00850065006161
Brand
Dario Blood Glucose Monitoring System
Company
LABSTYLE INNOVATION LTD
Model
1015-05
Device description
The Dario Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home to monitor the effectiveness of diabetes control.
Published
2019-02-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
K150817000
K163159000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150817000Dario Blood Glucose Monitoring SystemLabstyle Innovations, Ltd.2015-12-21NBW
K163159000Dario Blood Glucose Monitoring SystemLabstyle Innovations, Ltd.2017-07-19NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850065006161PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850065006161008500650061618500650061610850065006161

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
600039072
Device count
1
DM exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850065006444Dario Blood Glucose Monitoring System & Dario Membership1173-052019-11-06
00850065006246Dario Starter Kit1146-052018-10-28
00850065006741Dario® USB-C Blood Glucose Monitoring System- Welcome Kit1264-052023-12-21
00850065006758Dario® USB-C Blood Glucose Monitoring System - Starter Kit1265-052023-12-21
00850065006390Dario® USB-C Blood Glucose Monitoring System1152-052019-10-28
00850065006406Dario® USB-C Blood Glucose Monitoring System - Starter Kit1200-052019-10-28
00850065006222Dario 100 Sterile Lancets1121-052021-08-10
00850065006659Dario Super Saver MIB-Supplies1216-052021-07-15
0085006500601750 Dario Blood Glucose Test Strip 1024-012017-06-12
00850065006024100 Blood Glucose Test Strip1074-012017-06-12
00850065006048Dario Glucose Control Solution1054-012017-06-12
0085006500610925 Blood Glucose Test Strip1105-052017-06-12
00850065006567Dario 300 Test Strips Bundle1212-052020-08-26
00850065006574Dario 200 Test Strips Bundle1213-052020-08-26
00850065006505Dario USB-C Blood Glucose Monitoring System & Dario Membership1193-052020-02-24
00850065006451Dario LC Blood Glucose Monitoring System & Dario Membership1183-052019-11-06
00850065006253Dario LC Starter Kit1147-052018-10-28
00850065006000Dario Blood Glucose Monitoring System1015-012017-06-12
00850065006154Dario LC Blood Glucose Monitoring System1138-052018-04-26
0085006500617825 Blood Glucose Test Strip1120-052018-04-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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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
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06225000563858Be Smart Blood Glucose MeterEPS BIO TECHNOLOGY CORP.NBW2026-05-07
08500835120024Diabetes Starter KitOptum Distribution Center, LLCNBW2026-04-21
30732671309403PipAMITY HOLDINGS, LLCNBW2026-04-16
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30050428284392CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2025-11-30
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10840330705681TRUE METRIX PROTRIVIDIA HEALTH, INC.NBW2025-10-02
10385540109749CareSens SAgaMatrix, Inc.NBW2025-08-04
00850044118236iHealthiHealth Labs Inc.NBW2024-05-28