ABOUND® 7770

GUDID 50301937770512

Welcome kit - contains: CONTOUR® NEXT ONE Blood Glucose Monitoring System kit (Primary DI Number 00301939763012), 1 carton of CONTOUR® NEXT ONE Blood Glucose Test Strips (Package DI Number 00301937312212), 100 MICROLET® lancets (provided sterile), recipe cards, activity cards, resistance bands (labeled latex free), relaxation mask.

ASCENSIA DIABETES CARE US INC.

Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip

• Primary Device ID: 50301937770512
• NIH Device Record Key: 0c8a238d-b947-453f-ac89-8704bc6c881e
• Commercial Distribution Discontinuation: 2020-05-11
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ABOUND®
• Version Model Number: 7770
• Catalog Number: 7770
• Company DUNS: 080028910
• Company Name: ASCENSIA DIABETES CARE US INC.
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-888-890-8577
• Email: support@contournext.com
• Phone: 1-888-890-8577
• Email: support@contournext.com
• Phone: 1-888-890-8577
• Email: support@contournext.com
• Phone: 1-888-890-8577
• Email: support@contournext.com
• Phone: 1-888-890-8577
• Email: support@contournext.com
• Phone: 1-888-890-8577
• Email: support@contournext.com
• Phone: 1-888-890-8577
• Email: support@contournext.com
• Phone: 1-888-890-8577
• Email: support@contournext.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	40301937770515 [Primary]
GS1	50301937770512 [Package]; Contains: 40301937770515; Package: shipper/case [8 Units]; Discontinued: 2020-05-11; Not in Commercial Distribution

FDA Product Code

• FMK: Lancet, Blood

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-08-02
• Device Publish Date: 2019-11-21

On-Brand Devices [ABOUND®]

• 40301937750517: Welcome kit - contains: CONTOUR® NEXT ONE Blood Glucose Monitoring System kit (Primary DI Numbe
• 50301937770512: Welcome kit - contains: CONTOUR® NEXT ONE Blood Glucose Monitoring System kit (Primary DI Numbe