BREEZE® 2 1489A

GUDID 50301931489014

Control Solution - Normal, 1 x 2.5 mL

ASCENSIA DIABETES CARE US INC.

Glucose IVD, control

• Primary Device ID: 50301931489014
• NIH Device Record Key: a01eae00-4bd9-43e7-87f8-b4da6afa5153
• Commercial Distribution Discontinuation: 2018-01-19
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: BREEZE® 2
• Version Model Number: 1489A
• Catalog Number: 1489A
• 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: 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

Operating and Storage Conditions

• 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.
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00301931489019 [Package]; Contains: 10301931489016; Package: carton [1 Units]; Discontinued: 2018-01-19; Not in Commercial Distribution
NDC/NHRIC	0193-1489-01 [Secondary]
GS1	10301931489016 [Primary]
GS1	40301931489017 [Package]; Contains: 00301931489019; Package: in.shipper/sm.case [12 Units]; Discontinued: 2018-01-19; Not in Commercial Distribution
GS1	50301931489014 [Package]; Contains: 40301931489017; Package: out.shipper/lg.case [32 Units]; Discontinued: 2018-01-19; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062347

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

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