One Touch SureSoft

GUDID 20353885006839

One Touch SureSoft Single Use Disposable Lancing Device

LifeScan Europe GmbH

Manual blood lancing device, single-use

• Primary Device ID: 20353885006839
• NIH Device Record Key: 9cef3b34-a2a6-465e-ad77-6c75454930b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: One Touch SureSoft
• Version Model Number: 021-140
• Company DUNS: 480240820
• Company Name: LifeScan Europe GmbH
• Device Count: 200
• 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: 28 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00353885006835 [Primary]
GS1	20353885006839 [Package]; Contains: 00353885006835; Package: [20 Units]; In Commercial Distribution
NDC/NHRIC	53885-140-20 [Secondary]
GS1	80353885006831 [Unit of Use]

FDA Product Code

• FMK: Lancet, Blood

Sterilization

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

[20353885006839]

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

On-Brand Devices [One Touch SureSoft ]

• 20353885006839: One Touch SureSoft Single Use Disposable Lancing Device
• 53885-139-20: One Touch SureSoft Single Use Disposable Lancing Device