GLUCO-CARE 4013

GUDID 00810008217528

The GLUCO-CARE® HS100 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). It is intended for self-testing by people with diabetes at home as an aid to monitor the effective- ness of diabetes control. It should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis of or screening for diabetes or for neonatal use. The GLUCO-CARE® HS100 Blood Glucose Monitoring System is comprised of the GLUCO-CARE® HS100 Blood Glucose Meter and GLUCO-CARE® HS100 Blood Glucose Test Strip.

MediVena, LLC

Glucose monitoring system IVD, home-use

• Primary Device ID: 00810008217528
• NIH Device Record Key: 5266c80e-ba33-44a9-8980-fbe6a2babf7f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GLUCO-CARE
• Version Model Number: HS100
• Catalog Number: 4013
• Company DUNS: 080740980
• Company Name: MediVena, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1-404-514-2586
• Email: info@medivena.com
• Phone: +1-404-514-2586
• Email: info@medivena.com
• Phone: +1-404-514-2586
• Email: info@medivena.com
• Phone: +1-404-514-2586
• Email: info@medivena.com
• Phone: +1-404-514-2586
• Email: info@medivena.com
• Phone: +1-404-514-2586
• Email: info@medivena.com
• Phone: +1-404-514-2586
• Email: info@medivena.com
• Phone: +1-404-514-2586
• Email: info@medivena.com
• Phone: +1-404-514-2586
• Email: info@medivena.com
• Phone: +1-404-514-2586
• Email: info@medivena.com
• Phone: +1-404-514-2586
• Email: info@medivena.com
• Phone: +1-404-514-2586
• Email: info@medivena.com
• Phone: +1-404-514-2586
• Email: info@medivena.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810008217511 [Primary]
GS1	00810008217528 [Package]; Contains: 00810008217511; Package: case [72 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182046

FDA Product Code

• NBW: System, Test, Blood Glucose, Over The Counter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-17
• Device Publish Date: 2025-01-09

On-Brand Devices [GLUCO-CARE]

• 00810008217528: The GLUCO-CARE® HS100 Blood Glucose Monitoring System is intended for the quantitative measurem
• 00810008217504: The GLUCO-CARE® HS100 Blood Glucose Monitoring System is intended for the quantitative measurem
• 00810008215579: GLUCO-CARE test strips are intended for use with GLUCO-CARE glucose meters for the quantitative