OneTouch Verio 022-898

GUDID 20353885009755

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: 20353885009755
• NIH Device Record Key: 08663b33-2e16-4388-89af-2a5b433f2e7e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OneTouch Verio
• Version Model Number: 022-898
• Catalog Number: 022-898
• Company DUNS: 480240820
• Company Name: LifeScan Europe GmbH
• Device Count: 100
• 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	00353885009751 [Primary]
GS1	20353885009755 [Package]; Contains: 00353885009751; Package: Shipper case [24 Units]; In Commercial Distribution
NDC/NHRIC	53885-272-10 [Secondary]
GS1	80353885009757 [Unit of Use]

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

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