On Call Vivid Blood Glucose Test Strips

GUDID 20682607556223

Blood Glucose Test Strips, box of 50 strips

ACON LABORATORIES, INC.

Home-use/point-of-care blood glucose monitoring system IVD Home-use/point-of-care blood glucose monitoring system IVD

• Primary Device ID: 20682607556223
• NIH Device Record Key: 37114c05-485a-4c9c-9830-844eaa9c4b85
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: On Call Vivid Blood Glucose Test Strips
• Version Model Number: G135-102
• Company DUNS: 781100966
• Company Name: ACON LABORATORIES, 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00682607000050 [Unit of Use]
GS1	00682607556229 [Primary]
GS1	10682607556226 [Package]; Contains: 00682607556229; Package: case [12 Units]; In Commercial Distribution
GS1	20682607556223 [Package]; Contains: 10682607556226; Package: carton [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112653

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [On Call Vivid Blood Glucose Test Strips]

• 20682607556223: Blood Glucose Test Strips, box of 50 strips
• 00682607000036: Blood Glucose Test Strips, vial of 50 strips
• 00682607000029: Blood Glucose Test Strips, vial of 10 strips