CONTOUR®NEXT and MICROLET® 9781

GUDID 40301939781519

Mixed product shipper case containing 3 cartons of CONTOUR®NEXT Blood Glucose Test Strips (Package DI Number 00301937312212) and 300 MICROLET® lancets

ASCENSIA DIABETES CARE US INC.

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• Primary Device ID: 40301939781519
• NIH Device Record Key: 1dcfb81b-9854-4ed1-9b8f-db7e1ea4318e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CONTOUR®NEXT and MICROLET®
• Version Model Number: 9781
• Catalog Number: 9781
• 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: true
• 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: 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 Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	40301939781519 [Primary]

FDA Product Code

• FMK: Lancet, Blood

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: 2018-12-31
• Device Publish Date: 2018-11-30

On-Brand Devices [CONTOUR®NEXT and MICROLET®]

• 40301939782516: Mixed product shipper case containing 1 carton of CONTOUR®NEXT Blood Glucose Test Strips (Packa
• 40301939781519: Mixed product shipper case containing 3 cartons of CONTOUR®NEXT Blood Glucose Test Strips (Pack