OneTouch Lancing Device

GUDID 00353885012126

One Touch Lancing Device Warr

LifeScan Europe GmbH

Manual blood lancing device, reusable

• Primary Device ID: 00353885012126
• NIH Device Record Key: c2228549-3fa4-43c8-81eb-23ee782d11b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OneTouch Lancing Device
• Version Model Number: 021-242
• Company DUNS: 480240820
• Company Name: LifeScan Europe GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00353885012126 [Primary]
GS1	20353885012120 [Package]; Package: Shipper case [140 Units]; In Commercial Distribution

FDA Product Code

• FMK: Lancet, Blood

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: 2020-04-21
• Device Publish Date: 2020-04-13

Devices Manufactured by LifeScan Europe GmbH

• 20353885012830 - OneTouch Ultra Plus Flex: 2024-02-08 OneTouch Ultra Plus Flex™ Blood Glucose Monitoring System
• 20353885012106 - OneTouch Ultra Plus Flex: 2022-09-08 OneTouch Ultra Plus Flex™ Blood Glucose Monitoring System
• 20353885012618 - OneTouch Verio: 2022-09-08 OneTouch Verio Test Strips. For Blood Glucose testing with OneTouch Verio Family of meters. For in vitro diagnostic use. For sel
• 20353885012625 - OneTouch Ultra Plus Flex: 2022-09-08 OneTouch Ultra Plus Flex™ Blood Glucose Monitoring System
• 20353885012632 - OneTouch Ultra Plus: 2022-09-08 OneTouch Ultra® Plus strips work with OneTouch Ultra Plus Flex(TM) meter.
• 80353885012641 - OneTouch Ultra Plus: 2022-09-08 OneTouch Ultra Plus™ Level 3 Control Solution for Use with OneTouch Ultra Plus Flex™ Meter.
• 20353885012687 - OneTouch Ultra Plus: 2022-09-08 OneTouch Ultra Plus™ Level 4 Control Solution for Use with OneTouch Ultra Plus Flex™ Meter.
• 20353885012472 - OneTouch Verio Reflect: 2022-05-27 OneTouch Verio Reflect Blood Glucose Monitoring System. Starter Kit.