ONE-CARE 4007

GUDID 00810008210512

ONE-CARE test strips are intended for use with ONE-CARE glucose meters for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). ONE-CARE system can be used at home (over the counter OTC) by persons with diabetes. Test strips require small blood samples size of 0.5ul to provide accurate and fast results within 5 seconds. The system is based on auto-coding technology and no programming is needed when using new batch of test strips.

MediVena, LLC

Glucose monitoring system IVD, home-use

• Primary Device ID: 00810008210512
• NIH Device Record Key: 7be6efee-a514-458f-8c34-7ba6ccfd754c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ONE-CARE
• Version Model Number: AC500
• Catalog Number: 4007
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: 404-514-2586
• Email: info@medivena.com
• Phone: 404-514-2586
• Email: info@medivena.com
• Phone: 404-514-2586
• Email: info@medivena.com
• Phone: 404-514-2586
• Email: info@medivena.com
• Phone: 404-514-2586
• Email: info@medivena.com
• Phone: 404-514-2586
• Email: info@medivena.com
• Phone: 404-514-2586
• Email: info@medivena.com
• Phone: 404-514-2586
• Email: info@medivena.com
• Phone: 404-514-2586
• Email: info@medivena.com
• Phone: 404-514-2586
• Email: info@medivena.com
• Phone: 404-514-2586
• Email: info@medivena.com
• Phone: 404-514-2586
• Email: info@medivena.com
• Phone: 404-514-2586
• Email: info@medivena.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810008210369 [Primary]
GS1	00810008210512 [Package]; Contains: 00810008210369; Package: inner pack [280 Units]; In Commercial Distribution
GS1	00810008210529 [Package]; Contains: 00810008210369; Package: case [560 Units]; In Commercial Distribution

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: 2023-09-18
• Device Publish Date: 2023-09-10

On-Brand Devices [ONE-CARE]

• 00810008210994: ONE-CARE Control Solution (Level 1 – Low and Level 3 - High) contains a known amount of glucos
• 00810008210512: ONE-CARE test strips are intended for use with ONE-CARE glucose meters for the quantitative meas
• 00810008210451: ONE-CARE glucose monitoring system is intended for the quantitative measurement of glucose in fr
• 00810008210499: ONE-CARE PRO test strips are intended for use with ONE-CARE PRO glucose meters for the quantitat
• 00810008210031: ONE-CARE PRO glucose monitoring system is intended for the quantitative measurement of glucose i
• 00810008212103: ONE-CARE OPTI Safety Pen Needles 30G x 8mm offer safety solution as the needle is automatically
• 00810008211939: ONE-CARE OPTI Safety Pen Needles offer safety solution as the needle is automatically shielded a
• 00810008212080: ONE-CARE DUO Safety Pen Needles are intended for use with a pen injector device for the subcutan