OneTouch Ultra Plus Flex 024-366

GUDID 20353885012830

OneTouch Ultra Plus Flex™ Blood Glucose Monitoring System

LifeScan Europe GmbH

Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use Glucose monitoring system IVD, home-use

• Primary Device ID: 20353885012830
• NIH Device Record Key: b1d95dfc-1d38-405a-8899-da7a98d7ad55
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OneTouch Ultra Plus Flex
• Version Model Number: 024-366
• Catalog Number: 024-366
• 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	00353885012836 [Primary]
GS1	20353885012830 [Package]; Contains: 00353885012836; Package: Shipper [4 Units]; In Commercial Distribution

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: 2024-02-08
• Device Publish Date: 2024-01-31

On-Brand Devices [OneTouch Ultra Plus Flex]

• 20353885012625: OneTouch Ultra Plus Flex™ Blood Glucose Monitoring System
• 20353885012106: OneTouch Ultra Plus Flex™ Blood Glucose Monitoring System
• 20353885012830: OneTouch Ultra Plus Flex™ Blood Glucose Monitoring System