BREEZE® 2 1465A

GUDID 40301931465509

Blood Glucose Test Strips. Sold in a carton of 50 Test Strips (5 Discs).

ASCENSIA DIABETES CARE US INC.

Glucose monitoring system IVD, home-use

• Primary Device ID: 40301931465509
• NIH Device Record Key: f42896e9-b44e-4fee-af95-47066aa8de2e
• Commercial Distribution Discontinuation: 2018-06-27
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: BREEZE® 2
• Version Model Number: 1465A
• Catalog Number: 1465A
• Company DUNS: 080028910
• Company Name: ASCENSIA DIABETES CARE US INC.
• Device Count: 10
• 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: false
• 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
• 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.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Do not use after expiration date.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Do not use after expiration date.
• 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
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight. Do not use after expiration date.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00301931465013 [Unit of Use]
GS1	00301931465501 [Package]; Contains: 10301931465508; Package: carton [5 Units]; Discontinued: 2018-06-27; Not in Commercial Distribution
NDC/NHRIC	0193-1465-50 [Secondary]
GS1	10301931465508 [Package]; Contains: 20301931465505; Package: Blister/pouch [1 Units]; Discontinued: 2018-06-27; Not in Commercial Distribution
GS1	20301931465505 [Primary]
GS1	40301931465509 [Package]; Contains: 00301931465501; Package: shipper/case [24 Units]; Discontinued: 2018-06-27; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062347

FDA Product Code

• CGA: Glucose Oxidase, 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: 2019-06-07
• Device Publish Date: 2016-09-16

On-Brand Devices [BREEZE® 2]

• 40301931468500: Blood Glucose Test Strips. Sold in a carton of 50 Test Strips (5 Discs).
• 40301931467503: Blood Glucose Test Strips. Sold in a carton of 50 Test Strips (5 Discs).
• 00301931466218: Blood Glucose Test Strips. Sold in a carton of 100 Test Strips (10 Discs).
• 40301931465509: Blood Glucose Test Strips. Sold in a carton of 50 Test Strips (5 Discs).
• 50301931491017: Control Solution - High, 1 x 2.5 mL
• 50301931490010: Control Solution - Low, 1 x 2.5 mL
• 50301931489014: Control Solution - Normal, 1 x 2.5 mL