The GLUCOCARD Shine Express Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh and calf.

The GLUCOCARD Shine Express Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh and calf.
GLUCOCARD® Shine Express Blood Glucose Monitoring System - 544110

Device Description

A 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.

Environmental Conditions

Handling Environment Humidity - Percent (%) Relative Humidity

90.00
10.00

Handling Environment Temperature - Degrees Fahrenheit

111.20
42.80

Storage Environment Humidity - Percent (%) Relative Humidity

80.00
20.00

Storage Environment Temperature - Degrees Fahrenheit

122.00
32.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: NBW

Device Name: System, Test, Blood Glucose, Over The Counter

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 862.1345

Third Party Flag: N

Medical Specialty: CH

Device Identifiers

Device Id: 20015482544106

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10015482544109

Package Quantity: 16

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Master Shipper

Device Id: 10015482544109

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00015482544102

Package Quantity: 4

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Case Shipper

Device Id: 00015482544102

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A