CONTOUR® NEXT ONE 9765

GUDID 40301939765014

Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose. Kit contains: CONTOUR® NEXT ONE Meter; Lancing Device; 10 MICROLET® Colored Lancets (provided sterile); User Guide (including CONTOUR DIABETES app download instructions); Quick Reference Guide; Carrying Case; Web Registration / Warranty Card; CONTOUR® NEXT Control Solution.

ASCENSIA DIABETES CARE US INC.

Glucose monitoring system IVD, home-use

• Primary Device ID: 40301939765014
• NIH Device Record Key: a73419a4-5926-4492-aef9-889b6678f03d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CONTOUR® NEXT ONE
• Version Model Number: 9765
• Catalog Number: 9765
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-800-348-8100
• Email: support@contournext.com
• Phone: 1-800-348-8100
• Email: support@contournext.com
• Phone: 1-800-348-8100
• Email: support@contournext.com
• Phone: 1-800-348-8100
• Email: support@contournext.com
• Phone: 1-800-348-8100
• Email: support@contournext.com
• Phone: 1-800-348-8100
• Email: support@contournext.com
• Phone: 1-800-348-8100
• Email: support@contournext.com
• Phone: 1-800-348-8100
• Email: support@contournext.com
• Phone: 1-800-348-8100
• Email: support@contournext.com
• Phone: 1-800-348-8100
• Email: support@contournext.com
• Phone: 1-800-348-8100
• Email: support@contournext.com
• Phone: 1-800-348-8100
• Email: support@contournext.com
• Phone: 1-800-348-8100
• Email: support@contournext.com
• Phone: 1-800-348-8100
• Email: support@contournext.com
• Phone: 1-800-348-8100
• Email: support@contournext.com
• Phone: 1-800-348-8100
• Email: support@contournext.com
• Phone: 1-800-348-8100
• Email: support@contournext.com
• Phone: 1-800-348-8100
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00301939765016 [Primary]
NDC/NHRIC	0193-9765-01 [Secondary]
GS1	40301939765014 [Package]; Contains: 00301939765016; Package: shipper/case [4 Units]; In Commercial Distribution

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: 2016-12-16

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