CONTOUR® 7080G

GUDID 40301939727210

Blood Glucose Test strips. Sold in a carton with a single bottle (50 test strips - NDC # 0193-7080-50), or in a carton of two bottles (100 test strips total - NDC # 0193-7090-21).

ASCENSIA DIABETES CARE US INC.

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• Primary Device ID: 40301939727210
• NIH Device Record Key: 806f9ad7-8f79-4fef-8a6a-1023a14a3476
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CONTOUR®
• Version Model Number: 7080G
• Catalog Number: 7080G
• Company DUNS: 080028910
• Company Name: ASCENSIA DIABETES CARE US INC.
• Device Count: 50
• 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: 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 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store test strips in their original bottle only. Always close the lid tightly immediately after removing a test strip. Do not use after expiration date.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store test strips in their original bottle only. Always close the lid tightly immediately after removing a test strip. Do not use after expiration date.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store test strips in their original bottle only. Always close the lid tightly immediately after removing a test strip. Do not use after expiration date.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store test strips in their original bottle only. Always close the lid tightly immediately after removing a test strip. Do not use after expiration date.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store test strips in their original bottle only. Always close the lid tightly immediately after removing a test strip. Do not use after expiration date.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store test strips in their original bottle only. Always close the lid tightly immediately after removing a test strip. Do not use after expiration date.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store test strips in their original bottle only. Always close the lid tightly immediately after removing a test strip. Do not use after expiration date.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store test strips in their original bottle only. Always close the lid tightly immediately after removing a test strip. Do not use after expiration date.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00301937080012 [Unit of Use]
GS1	00301937080500 [Package]; Contains: 10301937080507; Package: carton [1 Units]; In Commercial Distribution
GS1	00301937090219 [Package]; Contains: 10301937080507; Package: carton [2 Units]; In Commercial Distribution
NDC/NHRIC	0193-7080-50 [Secondary]
GS1	10301937080507 [Primary]
GS1	40301937080508 [Package]; Contains: 00301937080500; Package: shipper/case [24 Units]; In Commercial Distribution
GS1	40301937090217 [Package]; Contains: 00301937090219; Package: shipper/case [12 Units]; In Commercial Distribution
GS1	40301939602043 [Package]; Contains: 00301937080500; Package: shipper / speed pack [4 Units]; In Commercial Distribution
GS1	40301939603040 [Package]; Contains: 00301937090219; Package: shipper / speed pack [4 Units]; In Commercial Distribution
GS1	40301939726503 [Package]; Contains: 00301937080500; Package: shipper/case [24 Units]; Discontinued: 2017-07-31; Not in Commercial Distribution
GS1	40301939727210 [Package]; Contains: 00301937090219; Package: shipper/case [12 Units]; Discontinued: 2017-07-31; Not 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: 4
• Public Version Date: 2021-08-02
• Device Publish Date: 2016-09-16

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• 40301939727210: Blood Glucose Test strips. Sold in a carton with a single bottle (50 test strips - NDC # 0193-70
• 40301939725254: Blood Glucose Test strips. 25 test strips.