OneTouch Ultra2 021-100

GUDID 20353885008857

OneTouch Ultra2 Blood Glucose Monitoring System with Delica Lancing Device, not for resale or reimbursement. Uses OneTouch Ultra Blue Test strip

LifeScan Europe GmbH

Glucose IVD, kit, electrometry

• Primary Device ID: 20353885008857
• NIH Device Record Key: 245f3a44-cc25-49bf-90ac-278bde9d77e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OneTouch Ultra2
• Version Model Number: 021-100
• Catalog Number: 021-100
• Company DUNS: 480240820
• Company Name: LifeScan Europe GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• 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: +1(800)227-8862
• Email: XX@XX.XX

Device Dimensions

• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge
• Needle Gauge: 30 Gauge

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Operating Altitude up to 10000 Feet
• Special Storage Condition, Specify: Between 0 and 0 *Operating Altitude up to 10000 Feet
• Special Storage Condition, Specify: Between 0 and 0 *Operating Altitude up to 10000 Feet
• Special Storage Condition, Specify: Between 0 and 0 *Operating Altitude up to 10000 Feet
• Special Storage Condition, Specify: Between 0 and 0 *Operating Altitude up to 10000 Feet

Device Identifiers

Device Issuing Agency	Device ID
GS1	00353885008853 [Primary]
GS1	20353885008857 [Package]; Contains: 00353885008853; Package: Shipper case [10 Units]; In Commercial Distribution
NDC/NHRIC	53885-452-10 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053529

FDA Product Code

• CGA: GLUCOSE OXIDASE, GLUCOSE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-07-26
• Device Publish Date: 2017-09-13

On-Brand Devices [OneTouch Ultra2]

• 20353885010515: OneTouch Ultra2 Blood Glucose Monitoring System. Uses the OneTouch Ultra Blue Test Strip.
• 20353885010010: OneTouch Ultra2 Blood Glucose Monitoring System. Uses the OneTouch Ultra Blue Test Strip. Not f
• 20353885008857: OneTouch Ultra2 Blood Glucose Monitoring System with Delica Lancing Device, not for resale or re
• 20353885008376: OneTouch Ultra2 Blood Glucose Monitoring Meter - Warranty replacement
• 20353885000271: OneTouch Ultra2 Blood Glucose Monitoring System with Delica Lancing Device. Uses OneTouch Ultra
• 20353885011857: OneTouch Ultra2 Blood Glucose Monitoring System.