On Call Express Blood Glucose Test Strips (10ct)

GUDID 00682607000081

Blood Glucose Test Strips, vial of 10 strips

ACON LABORATORIES, INC.

Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use

• Primary Device ID: 00682607000081
• NIH Device Record Key: 530a2cb9-c0a4-4f08-9b83-a08569cff392
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: On Call Express Blood Glucose Test Strips (10ct)
• Version Model Number: G135-10D
• Company DUNS: 781100966
• Company Name: ACON LABORATORIES, 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: 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: +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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00682607000081 [Primary]
GS1	00682607000111 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132086

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: 2
• Public Version Date: 2019-12-11
• Device Publish Date: 2018-08-16

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