On Call Plus Blood Glucose Test Strips

GUDID 20682607535211

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

• Primary Device ID: 20682607535211
• NIH Device Record Key: ff9dcb3c-466b-4782-bd40-a0588ea375df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: On Call Plus Blood Glucose Test Strips
• Version Model Number: G133-111
• 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: true
• 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
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• 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 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00682607000173 [Unit of Use]
GS1	00682607535217 [Primary]
GS1	20682607535211 [Package]; Contains: 00682607535217; Package: carton [120 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090057

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 Plus Blood Glucose Test Strips]

• 20682607535211: Blood Glucose Test Strips, box of 50 strips
• 00682607000159: Blood Glucose Test Strips, vial of 50 strips
• 00682607000142: Blood Glucose Test Strips, vial of 10 strips