OneTouch Verio Reflect

GUDID 20353885011710

OneTouch Verio Reflect Blood Glucose Monitoring System. Starter Kit

LifeScan Europe GmbH

Glucose monitoring system IVD, home-use

• Primary Device ID: 20353885011710
• NIH Device Record Key: 6618314e-1b23-4e25-9b0b-eca86419f323
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OneTouch Verio Reflect
• Version Model Number: 023-899
• 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

Device Dimensions

• Needle Gauge: 30 Gauge

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight and heat

Device Identifiers

Device Issuing Agency	Device ID
GS1	00353885011716 [Primary]
GS1	20353885011710 [Package]; Contains: 00353885011716; Package: shipper container [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193475

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-09
• Device Publish Date: 2020-02-28

On-Brand Devices [OneTouch Verio Reflect]

• 20353885011727: OneTouch Verio Reflect Blood Glucose Monitoring System. Warranty Kit
• 20353885011710: OneTouch Verio Reflect Blood Glucose Monitoring System. Starter Kit
• 20353885011703: 023-878
• 20353885011697: 023-927
• 20353885012434: OneTouch Verio Reflect Blood Glucose Monitoring System. Value Pack Kit
• 20353885012472: OneTouch Verio Reflect Blood Glucose Monitoring System. Starter Kit.
• 20353885012953: OneTouch Verio Reflect Blood Glucose Monitoring System. System Kit.