OneTouch Verio 024-174

GUDID 20353885012038

OneTouch Verio Test Strips. For Blood glucose testing with OneTouch Verio Family of Meters. For in vitro diagnostic use. For self-testing.

LifeScan Europe GmbH

Glucose IVD, kit, electrometry

• Primary Device ID: 20353885012038
• NIH Device Record Key: 7321f4dd-602c-4f69-b6c7-b7879b8c839a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OneTouch Verio
• Version Model Number: 024-174
• Catalog Number: 024-174
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00353885012034 [Primary]
GS1	20353885012038 [Package]; Contains: 00353885012034; Package: Shipper Case [450 Units]; In Commercial Distribution
NDC/NHRIC	53885-174-50 [Secondary]
GS1	80353885012030 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-20
• Device Publish Date: 2020-04-12

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