CONTOUR® 6707431

GUDID 00301937109010

Control Solution - Normal, 1 x 2.5 mL

ASCENSIA DIABETES CARE US INC.

Glucose IVD, control

• Primary Device ID: 00301937109010
• NIH Device Record Key: 4d135aa0-eb49-4352-91ae-8c063b5901b2
• Commercial Distribution Discontinuation: 2024-01-15
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: CONTOUR®
• Version Model Number: 7109B
• Catalog Number: 6707431
• 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: false
• 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
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00301937109010 [Package]; Contains: 10301937109017; Package: carton [1 Units]; Not in Commercial Distribution
NDC/NHRIC	0193-7109-01 [Secondary]
GS1	10301937109017 [Primary]
GS1	40301937109018 [Package]; Package: in.shipper/sm.case [12 Units]; Not in Commercial Distribution
GS1	50301937109015 [Package]; Contains: 40301937109018; Package: out.shipper/lg.case [32 Units]; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062058

FDA Product Code

• NBW: System, Test, Blood Glucose, Over The Counter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2024-11-06
• 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.