CONTOUR® 9545C

GUDID 40301939545012

Blood Glucose Monitoring System. 1 kit. For self-monitoring and management of blood glucose. In this kit you will find: CONTOUR® Blood Glucose Meter; 10 Blood Glucose Test Strips; Normal Control Solution; Quick Reference Guide; User Guide; Lancing Device; 10 Lancets (provided sterile); Logbook; Carrying Case; Warranty Card.

ASCENSIA DIABETES CARE US INC.

Glucose monitoring system IVD, home-use

• Primary Device ID: 40301939545012
• NIH Device Record Key: ab4fbf38-bf98-4be6-9111-5acc9834def5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CONTOUR®
• Version Model Number: 9545C
• Catalog Number: 9545C
• 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: true
• OTC Over-The-Counter: true

Customer Support Contacts

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

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Do not use after expiration dates.
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Do not use after expiration dates.
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Do not use after expiration dates.
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Do not use after expiration dates.
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Do not use after expiration dates.
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Do not use after expiration dates.
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Do not use after expiration dates.
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Do not use after expiration dates.
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Do not use after expiration dates.
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Do not use after expiration dates.
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Do not use after expiration dates.
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Do not use after expiration dates.
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Do not use after expiration dates.
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Do not use after expiration dates.
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Do not use after expiration dates.
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Do not use after expiration dates.
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Do not use after expiration dates.
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00301939545014 [Primary]
NDC/NHRIC	0193-9545-01 [Secondary]
GS1	40301939545012 [Package]; Contains: 00301939545014; Package: shipper/case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062058

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: 2016-09-16

On-Brand Devices [CONTOUR®]

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• 40301939727210: Blood Glucose Test strips. Sold in a carton with a single bottle (50 test strips - NDC # 0193-70
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• 50301937111018: Control Solution - High, 1 x 2.5 mL
• 50301937110011: Control Solution - Low, 1 x 2.5 mL
• 00301937109010: Control Solution - Normal, 1 x 2.5 mL
• 40301937099500: Blood Glucose Test strips. 50 test strips.
• 40301937098503: Blood Glucose Test strips. 50 test strips.
• 40301937097506: Blood Glucose Test strips. 50 test strips.