CONTOUR® NEXT GEN 90002902

GUDID 00301937917011

Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood glucose. Kit contains: CONTOUR® NEXT GEN blood glucose meter, Lancing Device, 10 MICROLET® lancets, User Guide, Quick Reference Guide, Carrying Case, Web Registration/Warranty Card.

ASCENSIA DIABETES CARE US INC.

Glucose monitoring system IVD, home-use

• Primary Device ID: 00301937917011
• NIH Device Record Key: fcdd595c-e7fd-4d13-a93b-f90362e6c0c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CONTOUR® NEXT GEN
• Version Model Number: 7917
• Catalog Number: 90002902
• 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: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com
• Phone: 800-348-8100
• Email: support@contournext.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00301937917011 [Primary]
GS1	40301937917019 [Package]; Package: shipper/case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193407

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: 2022-07-11
• Device Publish Date: 2022-07-01

On-Brand Devices [CONTOUR® NEXT GEN]

• 40301939658019: "Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood
• 40301937383012: "For self-testing, monitoring, and management of blood glucose. Kit contains: CONTOUR® NEXT GE
• 00301937917011: Blood Glucose Monitoring System. 1 kit. For self-testing, monitoring and management of blood g
• 40301939732016: "For self-testing, monitoring, and management of blood glucose. Kit contains: CONTOUR® NEXT GE
• 40301937922013: "For self-testing, monitoring, and management of blood glucose. Kit contains: CONTOUR® NEXT GE
• 40301939732023: "For self-testing, monitoring, and management of blood glucose. Kit contains: CONTOUR® NEXT GE