Linksun Blood Glucose Monitoring System

Trade name

Linksun Blood Glucose Monitoring System

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

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06939184631486

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

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6939184630021BK

Reference / catalog number

G-425-1/G-425S-1

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

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GS1

Risk category

IVDR risk classes

IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.

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IVDR Class C

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

The blood glucose monitoring system is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The blood glucose monitoring system is intended to be used by a single person and should not be shared. lt is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The blood glucose monitoring system should not be used for the diagnosis of or screening for diabetes. The Blood Glucose Monitoring System is not for use in neonates and not for near patient use.The Blood Glucose Monitoring System is comprised of Blood Glucose Meter, Blood Glucose Test Strips and Glucose Control Solutions. Test Strips Specification(100 pcs/vial)

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W010106010801BLOOD TEST STRIPS CONTROLS
• W0201060102BLOOD GLUCOSE METERS
• W0101060101GLUCOSE TEST STRIPS

1 warning recorded — scroll inside the panel to see all entries.

• CW011

  ◼ The Blood Glucose Monitoring System is not intended for use on neonates. ◼ The Blood Glucose Monitoring System is not intended for use on artery blood, neonates’ serum and plasma. ◼ The system can be used up to an altitude of 10744 feet. ◼ The following substances at levels greater than normal or therapeutic levels may cause significant interference (affect the result by greater than 10%) resulting in an inaccurate result: ascorbic acid, uric acid, hemoglobin, acetaminophen, Dopamine, L-dopa and Tolbutamide etc. These sub- stances do not affect test results in normal concentration but may affect test results in high concentration. Do not use haemolysis sample, icterus sample or high lipemia samples. ◼ Patients undergoing oxygen therapy may yield falsely lower results. ◼ Not for use for patients in a hyperglycemic-hyperosmolar state, with or without ketosis. ◼ Not for use on critically ill patients. ◼ Not to be used for patients who are dehydrated, hypertensive, hypotensive or in shock. ◼ Very low (less than 20%) or very high (more than 60%) red blood cell count (hematocrit) can lead to incorrect test results. If you do not know your hemarocrit level, please consult your health care provider. ◼ High temperature (more than 40oC(104oF)) and low temperature (less than 10oC (50oF)) may lead to incorrect test results. ◼ High humidity (more than 80%) and low humidity (less than 20%) may lead to incorrect test results.