Dario Blood Glucose Monitoring System

Primary DI
00850065006000
Brand
Dario Blood Glucose Monitoring System
Company
LABSTYLE INNOVATION LTD
Model
1015-01
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
2017-06-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150817000

Premarket Details#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850065006000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850065006000008500650060008500650060000850065006000

GMDN Terms#

Term, Definition table
TermDefinition
Home-use/point-of-care blood glucose/blood pressure monitoring systemA collection of devices designed to semi-quantitatively measure glucose in a specimen of whole blood in a short period, typically several minutes, and to noninvasively measure blood pressure. It typically consists of a portable analyser (a self-testing meter), reagents, test strips and accessories (e.g., a lancet), and a blood pressure cuff. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus. The device is normally available [non-prescription] over-the-counter (OTC) for home-use, but may also be used in a clinical setting for multi-patient monitoring of blood glucose and blood pressure.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600039072
Device count
1
DM exempt
true
Kit
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
00850065006161Dario Blood Glucose Monitoring System1015-052019-02-07
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
00850065006154Dario LC Blood Glucose Monitoring System1138-052018-04-26
0085006500617825 Blood Glucose Test Strip1120-052018-04-25