One Touch SureSoft

GUDID 53885-139-20

One Touch SureSoft Single Use Disposable Lancing Device

LifeScan Europe GmbH

Manual blood lancing device, single-use

• Primary Device ID: 53885-139-20
• NIH Device Record Key: b200b442-8a2a-4d2e-9ac3-562d15f65dcf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: One Touch SureSoft
• Version Model Number: 021-139
• 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: 21 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00353885006828 [Primary]
GS1	20353885006822 [Package]; Contains: 00353885006828; Package: [20 Units]; In Commercial Distribution
NDC/NHRIC	53885-139-20 [Secondary]
GS1	80353885006824 [Unit of Use]

FDA Product Code

• FMK: Lancet, Blood

Sterilization

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

[53885-139-20]

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