OneTouch Verio 022-269

GUDID 20353885007720

OneTouch Verio Blood Glucose Test Strips. In vitro Diagnostic. For Self-testing. Use with OneTouch Verio Family of Meters

LifeScan Europe GmbH

Glucose IVD, kit, electrometry

• Primary Device ID: 20353885007720
• NIH Device Record Key: 1c527588-ed82-4df1-b3ed-87974a0a53de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OneTouch Verio
• Version Model Number: 022-269
• Catalog Number: 022-269
• Company DUNS: 480240820
• Company Name: LifeScan Europe GmbH
• 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: true
• 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(888)567-3003
• Email: XX@XX.XX

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00353885007726 [Primary]
GS1	20353885007720 [Package]; Contains: 00353885007726; Package: Shipper case [240 Units]; In Commercial Distribution
GS1	80353885007722 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110637

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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