INFINITY™ Starter Kit G5-003SK

GUDID 00885502000006

U.S. DIAGNOSTICS INC.

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

• Primary Device ID: 00885502000006
• NIH Device Record Key: e416191c-8de3-4d85-997b-3d43bba783f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INFINITY™ Starter Kit
• Version Model Number: IGM-0024
• Catalog Number: G5-003SK
• 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

Device Dimensions

• Total Volume: 0.5 Microliter
• Total Volume: 0.5 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885502000006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082201

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: 2017-01-13

Devices Manufactured by U.S. DIAGNOSTICS INC.

• 00885502004004 - INFINITY™ Normal Control Solution: 2018-10-25
• 00885502004035 - EasyGluco™ Normal Control Solution: 2018-10-25
• 00885502015000 - INFINITY™ Low Control Solution: 2018-10-25
• 00885502015031 - EasyGluco™ Low Control Solution: 2018-10-25
• 00885502016007 - INFINITY™ High Control Solution: 2018-10-25
• 00885502016038 - EasyGluco™ High Control Solution: 2018-10-25
• 00885502000006 - INFINITY™ Starter Kit: 2018-07-06
• 00885502000006 - INFINITY™ Starter Kit: 2018-07-06
• 00885502000037 - EasyGluco™G2 Starter Kit: 2018-07-06