Control™ Starter Kit IGM-G3-003

GUDID 00885502000044

U.S. DIAGNOSTICS INC.

Glucose monitoring system IVD, home-use

• Primary Device ID: 00885502000044
• NIH Device Record Key: c0e656d4-8f48-4da4-b342-835a8282f57c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Control™ Starter Kit
• Version Model Number: IGM-0009
• Catalog Number: IGM-G3-003
• Company DUNS: 828116728
• Company Name: U.S. DIAGNOSTICS 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: true
• 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: 866-216-5308
• Email: jkupar@usdiagnostics.net
• Phone: 866-216-5308
• Email: jkupar@usdiagnostics.net
• Phone: 866-216-5308
• Email: jkupar@usdiagnostics.net
• Phone: 866-216-5308
• Email: jkupar@usdiagnostics.net
• Phone: 866-216-5308
• Email: jkupar@usdiagnostics.net
• Phone: 866-216-5308
• Email: jkupar@usdiagnostics.net
• Phone: 866-216-5308
• Email: jkupar@usdiagnostics.net
• Phone: 866-216-5308
• Email: jkupar@usdiagnostics.net
• Phone: 866-216-5308
• Email: jkupar@usdiagnostics.net
• Phone: 866-216-5308
• Email: jkupar@usdiagnostics.net
• Phone: 866-216-5308
• Email: jkupar@usdiagnostics.net
• Phone: 866-216-5308
• Email: jkupar@usdiagnostics.net
• Phone: 866-216-5308
• Email: jkupar@usdiagnostics.net
• Phone: 866-216-5308
• Email: jkupar@usdiagnostics.net
• Phone: 866-216-5308
• Email: jkupar@usdiagnostics.net

Device Dimensions

• Total Volume: 1 Microliter
• Total Volume: 1 Microliter
• Total Volume: 1 Microliter
• Total Volume: 1 Microliter
• Total Volume: 1 Microliter
• Total Volume: 1 Microliter
• Total Volume: 1 Microliter
• Total Volume: 1 Microliter
• Total Volume: 1 Microliter
• Total Volume: 1 Microliter
• Total Volume: 1 Microliter
• Total Volume: 1 Microliter
• Total Volume: 1 Microliter
• Total Volume: 1 Microliter
• Total Volume: 1 Microliter

Operating and Storage Conditions

• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885502000044 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043543

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: 2017-10-26

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