CONTOUR® NEXT and MICROLET® 9769

GUDID 40301939769517

Mixed product shipper case containing 2 cartons of CONTOUR® NEXT Blood Glucose Test Strips (Package DI Number 00301937312212) and 200 MICROLET® lancet

ASCENSIA DIABETES CARE US INC.

Blood lancing device tip Blood lancing device tip

• Primary Device ID: 40301939769517
• NIH Device Record Key: 3b818ecf-7b4b-4b69-ab69-3665c7101439
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CONTOUR® NEXT and MICROLET®
• Version Model Number: 9769
• Catalog Number: 9769
• 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: 1 (800) 348-8100
• Email: support@contournext.com
• Phone: 1 (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 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	40301939769517 [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: 2018-07-02
• Device Publish Date: 2018-06-01

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