OneTouch Verio 022-658

GUDID 20353885008727

OneTouch Verio Blood Glucose Monitoring System. For in vitro diagnostic use. For self-testing For Single Patient use only.

LifeScan Europe GmbH

Glucose monitoring system IVD, home-use

• Primary Device ID: 20353885008727
• NIH Device Record Key: 09d67854-a8a9-434a-a7a7-28653fff8b0a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OneTouch Verio
• Version Model Number: 022-658
• Catalog Number: 022-658
• 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

• Special Storage Condition, Specify: Between 0 and 0 *Operating Altitude up to 10000 Feet
• Special Storage Condition, Specify: Between 0 and 0 *Operating Altitude up to 10000 Feet
• Special Storage Condition, Specify: Between 0 and 0 *Operating Altitude up to 10000 Feet
• Special Storage Condition, Specify: Between 0 and 0 *Operating Altitude up to 10000 Feet

Device Identifiers

Device Issuing Agency	Device ID
GS1	00353885008723 [Primary]
GS1	20353885008727 [Package]; Contains: 00353885008723; Package: Shipper case [10 Units]; In Commercial Distribution
NDC/NHRIC	53885-658-01 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131363

FDA Product Code

• NBW: SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

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

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