ONE-CARE 4006

GUDID 00810008210451

ONE-CARE glucose monitoring system is intended 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. ONE-CARE glucose meter feature strip ejector for safe removal of used strip, large and user-friendly display, as well as 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. ONE-CARE glucose monitor automatically powers on and shuts down when the strip is inserted/ejected.

MediVena, LLC

Glucose monitoring system IVD, home-use

• Primary Device ID: 00810008210451
• NIH Device Record Key: cb44b534-e745-4929-a513-90efc0f1752f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ONE-CARE
• Version Model Number: AC500
• Catalog Number: 4006
• 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: 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: 4044221415
• Email: jarek.moleda@medivena.com
• Phone: 4044221415
• Email: jarek.moleda@medivena.com
• Phone: 4044221415
• Email: jarek.moleda@medivena.com
• Phone: 4044221415
• Email: jarek.moleda@medivena.com
• Phone: 4044221415
• Email: jarek.moleda@medivena.com
• Phone: 4044221415
• Email: jarek.moleda@medivena.com
• Phone: 4044221415
• Email: jarek.moleda@medivena.com
• Phone: 4044221415
• Email: jarek.moleda@medivena.com
• Phone: 4044221415
• Email: jarek.moleda@medivena.com
• Phone: 4044221415
• Email: jarek.moleda@medivena.com
• Phone: 4044221415
• Email: jarek.moleda@medivena.com
• Phone: 4044221415
• Email: jarek.moleda@medivena.com
• Phone: 4044221415
• Email: jarek.moleda@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	00810008210161 [Primary]
GS1	00810008210451 [Package]; Contains: 00810008210161; Package: case [80 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