CONTOUR® NEXT ONE, CONTOUR® NEXT EZ, and CONTOUR® 9647

GUDID 40301939647518

Mixed product shipper case containing 3 CONTOUR® NEXT ONE Blood Glucose Monitoring System kits (Primary DI Number 00301939763012), 3 CONTOUR® NEXT EZ

ASCENSIA DIABETES CARE US INC.

Glucose monitoring system IVD, home-use

• Primary Device ID: 40301939647518
• NIH Device Record Key: e7263558-ad0a-45b4-8bbe-814cc1616b33
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CONTOUR® NEXT ONE, CONTOUR® NEXT EZ, and CONTOUR®
• Version Model Number: 9647
• Catalog Number: 9647
• 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: false
• 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: true
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 18003488100
• Email: support@contournext.com
• Phone: 18003488100
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	40301939647518 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111268

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: 2017-11-17

Devices Manufactured by ASCENSIA DIABETES CARE US INC.

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