CONTOUR® NEXT ONE 9766

GUDID 40301939766011

Kit contains: CONTOUR® NEXT ONE Blood Glucose Monitoring System kit; MICROLET® NEXT Lancing Device; 4 bags of MICROLET® lancets (25 per bag; provided

ASCENSIA DIABETES CARE US INC.

Glucose monitoring system IVD, home-use

• Primary Device ID: 40301939766011
• NIH Device Record Key: e62e4b23-3f3d-4efa-9208-468525358a65
• Commercial Distribution Discontinuation: 2017-07-19
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: CONTOUR® NEXT ONE
• Version Model Number: 9766
• Catalog Number: 9766
• 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: 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: 1-855-691-6532
• Email: support@contournext.com
• Phone: 1-855-691-6532
• Email: support@contournext.com
• Phone: 1-855-691-6532
• Email: support@contournext.com
• Phone: 1-855-691-6532
• Email: support@contournext.com
• Phone: 1-855-691-6532
• Email: support@contournext.com
• Phone: 1-855-691-6532
• Email: support@contournext.com
• Phone: 1-855-691-6532
• Email: support@contournext.com
• Phone: 1-855-691-6532
• Email: support@contournext.com
• Phone: 1-855-691-6532
• Email: support@contournext.com
• Phone: 1-855-691-6532
• Email: support@contournext.com
• Phone: 1-855-691-6532
• Email: support@contournext.com
• Phone: 1-855-691-6532
• Email: support@contournext.com
• Phone: 1-855-691-6532
• Email: support@contournext.com
• Phone: 1-855-691-6532
• Email: support@contournext.com
• Phone: 1-855-691-6532
• Email: support@contournext.com
• Phone: 1-855-691-6532
• Email: support@contournext.com
• Phone: 1-855-691-6532
• Email: support@contournext.com
• Phone: 1-855-691-6532
• Email: support@contournext.com
• Phone: 1-855-691-6532
• Email: support@contournext.com
• Phone: 1-855-691-6532
• Email: support@contournext.com
• Phone: 1-855-691-6532
• Email: support@contournext.com
• Phone: 1-855-691-6532
• Email: support@contournext.com
• Phone: 1-855-691-6532
• Email: support@contournext.com
• Phone: 1-855-691-6532
• Email: support@contournext.com
• Phone: 1-855-691-6532
• Email: support@contournext.com
• Phone: 1-855-691-6532
• Email: support@contournext.com
• Phone: 1-855-691-6532
• Email: support@contournext.com
• Phone: 1-855-691-6532
• Email: support@contournext.com
• Phone: 1-855-691-6532
• Email: support@contournext.com
• Phone: 1-855-691-6532
• Email: support@contournext.com
• Phone: 1-855-691-6532
• Email: support@contournext.com
• Phone: 1-855-691-6532
• Email: support@contournext.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	40301939766011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160682

FDA Product Code

• LFR: Glucose Dehydrogenase, Glucose

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-17

On-Brand Devices [CONTOUR® NEXT ONE]

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• 40301937824010: Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood g
• 00301937818011: Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood g
• 40301939766011: Kit contains: CONTOUR® NEXT ONE Blood Glucose Monitoring System kit; MICROLET® NEXT Lancing De
• 40301937825017: Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood g
• 40301939550016: Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood g
• 40301937828018: Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood g