CONTOUR® NEXT and MICROLET® 7771

GUDID 50301937771519

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

ASCENSIA DIABETES CARE US INC.

Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip Blood lancing device tip

• Primary Device ID: 50301937771519
• NIH Device Record Key: 4848c545-0949-4c38-9d94-5ed10ebb2199
• Commercial Distribution Discontinuation: 2020-05-27
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: CONTOUR® NEXT and MICROLET®
• Version Model Number: 7771
• Catalog Number: 7771
• 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

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	40301937771512 [Primary]
GS1	50301937771519 [Package]; Contains: 40301937771512; Package: shipper/case [8 Units]; Discontinued: 2020-05-27; Not in Commercial Distribution

FDA Product Code

• FMK: Lancet, Blood

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-08-02
• Device Publish Date: 2019-11-21

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

• 40301939769517: Mixed product shipper case containing 2 cartons of CONTOUR® NEXT Blood Glucose Test Strips (Pac
• 40301937751514: Mixed product shipper case containing 3 cartons of CONTOUR® NEXT Blood Glucose Test Strips (Pac
• 50301937771519: Mixed product shipper case containing 3 cartons of CONTOUR® NEXT Blood Glucose Test Strips (Pac