CONTOUR® 6707105

GUDID 40301939725254

Blood Glucose Test strips. 25 test strips.

ASCENSIA DIABETES CARE US INC.

Glucose monitoring system IVD, home-use

• Primary Device ID: 40301939725254
• NIH Device Record Key: b201f486-ee9a-4b21-8d0e-a950d3712c81
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CONTOUR®
• Version Model Number: 7070A
• Catalog Number: 6707105
• Company DUNS: 080028910
• Company Name: ASCENSIA DIABETES CARE US INC.
• Device Count: 25
• 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
• Phone: +1(800)348-8100
• Email: support@contournext.com
• Phone: +1(800)348-8100
• Email: support@contournext.com
• Phone: +1(800)348-8100
• Email: support@contournext.com
• Phone: +1(800)348-8100
• Email: support@contournext.com
• Phone: +1(800)348-8100
• Email: support@contournext.com
• Phone: +1(800)348-8100
• Email: support@contournext.com
• Phone: +1(800)348-8100
• Email: support@contournext.com
• Phone: +1(800)348-8100
• Email: support@contournext.com
• Phone: +1(800)348-8100
• Email: support@contournext.com
• Phone: +1(800)348-8100
• Email: support@contournext.com
• Phone: +1(800)348-8100
• Email: support@contournext.com
• Phone: +1(800)348-8100
• Email: support@contournext.com
• Phone: +1(800)348-8100
• Email: support@contournext.com
• Phone: +1(800)348-8100
• Email: support@contournext.com
• Phone: +1(800)348-8100
• Email: support@contournext.com
• Phone: +1(800)348-8100
• Email: support@contournext.com
• Phone: +1(800)348-8100
• Email: support@contournext.com
• Phone: +1(800)348-8100
• Email: support@contournext.com
• Phone: +1(800)348-8100
• Email: support@contournext.com
• Phone: +1(800)348-8100
• Email: support@contournext.com
• Phone: +1(800)348-8100
• Email: support@contournext.com
• Phone: +1(800)348-8100
• Email: support@contournext.com
• Phone: +1(800)348-8100
• Email: support@contournext.com
• Phone: +1(800)348-8100
• Email: support@contournext.com
• Phone: +1(800)348-8100
• Email: support@contournext.com
• Phone: +1(800)348-8100
• Email: support@contournext.com
• Phone: +1(800)348-8100
• Email: support@contournext.com
• Phone: +1(800)348-8100
• Email: support@contournext.com
• Phone: +1(800)348-8100
• Email: support@contournext.com
• Phone: +1(800)348-8100
• 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
• 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.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• 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.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• 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.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• 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.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• 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.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• 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.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• 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.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• 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.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• 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.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• 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.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• 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.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• 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.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• 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.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• 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.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• 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.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• 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.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• 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.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• 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.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• 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.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• 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.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• 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.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• 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.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• 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.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• 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.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• 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.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• 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.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• 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.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• 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.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• 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.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• 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.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• 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.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0
• 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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00301937070013 [Unit of Use]
GS1	00301937070259 [Package]; Contains: 10301937070256; Package: carton [1 Units]; In Commercial Distribution
NDC/NHRIC	0193-7070-25 [Secondary]
GS1	10301937070256 [Primary]
GS1	40301937070257 [Package]; Contains: 00301937070259; Package: shipper/case [24 Units]; In Commercial Distribution
GS1	40301939725254 [Package]; Contains: 00301937070259; Package: shipper/case [24 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: 4
• Public Version Date: 2022-10-07
• Device Publish Date: 2016-09-16

On-Brand Devices [CONTOUR®]

• 40301939556018: Blood Glucose Monitoring System. For self-testing, monitoring and management of blood glucose. C
• 40301939545012: Blood Glucose Monitoring System. 1 kit. For self-monitoring and management of blood glucose. In
• 40301937189010: Blood Glucose Monitoring System. For self-monitoring and management of blood glucose. Contents:
• 40301937151017: Blood Glucose Monitoring System. 1 kit. For self-monitoring and management of blood glucose. T
• 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.
• 40301939507102: Blood Glucose Test strips. 10 test strips.
• 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.