OneTouch Ultrasoft

GUDID 20353885012441

OneTouch Ultrasoft Lancets

LifeScan Europe GmbH

Glucose monitoring system IVD, point-of-care Glucose monitoring system IVD, point-of-care Glucose monitoring system IVD, point-of-care Glucose monitoring system IVD, point-of-care Glucose monitoring system IVD, point-of-care Glucose monitoring system IVD, point-of-care Glucose monitoring system IVD, point-of-care Glucose monitoring system IVD, point-of-care Glucose monitoring system IVD, point-of-care Glucose monitoring system IVD, point-of-care Glucose monitoring system IVD, point-of-care Glucose monitoring system IVD, point-of-care Glucose monitoring system IVD, point-of-care Glucose monitoring system IVD, point-of-care Glucose monitoring system IVD, point-of-care Glucose monitoring system IVD, point-of-care

• Primary Device ID: 20353885012441
• NIH Device Record Key: 260a47c1-c4db-4263-8f30-5ed49da6fbdd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OneTouch Ultrasoft
• Version Model Number: 011-423
• Company DUNS: 480240820
• Company Name: LifeScan Europe GmbH
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 8002278862
• Email: XX@XX.XX
• Phone: 8002278862
• Email: XX@XX.XX
• Phone: 8002278862
• Email: XX@XX.XX
• Phone: 8002278862
• Email: XX@XX.XX
• Phone: 8002278862
• Email: XX@XX.XX
• Phone: 8002278862
• Email: XX@XX.XX
• Phone: 8002278862
• Email: XX@XX.XX
• Phone: 8002278862
• Email: XX@XX.XX
• Phone: 8002278862
• Email: XX@XX.XX
• Phone: 8002278862
• Email: XX@XX.XX
• Phone: 8002278862
• Email: XX@XX.XX
• Phone: 8002278862
• Email: XX@XX.XX
• Phone: 8002278862
• Email: XX@XX.XX
• Phone: 8002278862
• Email: XX@XX.XX
• Phone: 8002278862
• Email: XX@XX.XX
• Phone: 8002278862
• Email: XX@XX.XX

Device Dimensions

• Needle Gauge: 28 Gauge
• Needle Gauge: 28 Gauge
• Needle Gauge: 28 Gauge
• Needle Gauge: 28 Gauge
• Needle Gauge: 28 Gauge
• Needle Gauge: 28 Gauge
• Needle Gauge: 28 Gauge
• Needle Gauge: 28 Gauge
• Needle Gauge: 28 Gauge
• Needle Gauge: 28 Gauge
• Needle Gauge: 28 Gauge
• Needle Gauge: 28 Gauge
• Needle Gauge: 28 Gauge
• Needle Gauge: 28 Gauge
• Needle Gauge: 28 Gauge
• Needle Gauge: 28 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00353885012447 [Primary]
GS1	20353885012441 [Package]; Contains: 00353885012447; Package: Shipper case [450 Units]; In Commercial Distribution
GS1	80353885012443 [Unit of Use]

FDA Product Code

• FMK: Lancet, Blood

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-08
• Device Publish Date: 2021-09-30

On-Brand Devices [OneTouch Ultrasoft ]

• 20353885393106: OneTouch Ultrasoft Lancets
• 20353885012441: OneTouch Ultrasoft Lancets