OneTouch Verio IQ 022-268

GUDID 20353885007713

OneTouch Verio IQ Blood Glucose Monitoring System. For in vitro diagnostic use. For self-testing

LifeScan Europe GmbH

Glucose monitoring system IVD, home-use

• Primary Device ID: 20353885007713
• NIH Device Record Key: 249266ad-1259-4e61-b6cf-1df314be2eee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OneTouch Verio IQ
• Version Model Number: 022-268
• Catalog Number: 022-268
• Company DUNS: 480240820
• Company Name: LifeScan Europe GmbH
• 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: true
• Manufacturing Date: true
• 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(888)567-3003
• Email: XX@XX.XX

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

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	00353885007719 [Primary]
GS1	20353885007713 [Package]; Contains: 00353885007719; Package: Shipper case [10 Units]; In Commercial Distribution
NDC/NHRIC	53885-854-01 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110637

FDA Product Code

• LFR: Glucose dehydrogenase, 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: 4
• Public Version Date: 2019-07-26
• Device Publish Date: 2017-09-13

On-Brand Devices [OneTouch Verio IQ]

• 20353885008406: OneTouch Verio IQ Blood Glucose Monitoring System. For in vitro diagnostic use. For self-testing
• 20353885007713: OneTouch Verio IQ Blood Glucose Monitoring System. For in vitro diagnostic use. For self-testing
• 20353885007706: OneTouch Verio IQ Blood Glucose Monitoring System. For In vitro diagnostic use. For self-testing