OneTouch SureSoft

GUDID 20353885006846

One Touch SureSoft Single Use Disposable Lancing Device

LifeScan Europe GmbH

Manual blood lancing device, single-use

• Primary Device ID: 20353885006846
• NIH Device Record Key: c43fc9c7-bf40-46b1-8cbc-3e3bf2e94abc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OneTouch SureSoft
• Version Model Number: 021-141
• Company DUNS: 480240820
• Company Name: LifeScan Europe GmbH
• Device Count: 100
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Needle Gauge: 18 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00353885006842 [Primary]
GS1	20353885006846 [Package]; Contains: 00353885006842; Package: [40 Units]; In Commercial Distribution
NDC/NHRIC	53885-141-10 [Secondary]
GS1	80353885006824 [Unit of Use]

FDA Product Code

• FMK: Lancet, Blood

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[20353885006846]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-11
• Device Publish Date: 2020-02-03

Devices Manufactured by LifeScan Europe GmbH

• 20353885012793 - OneTouch Verio Flex: 2024-10-02 OneTouch Verio Flex Blood Glucose Monitoring System
• 20353885012953 - OneTouch Verio Reflect: 2024-05-27 OneTouch Verio Reflect Blood Glucose Monitoring System. System Kit.
• 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.