OneTouch Ultramini 021-419

GUDID 20353885001285

OneTouch Ultramini Blood Glucose Monitoring System with Delica Lancing Device. Uses OneTouch Ultra Blue Test strip

LifeScan Europe GmbH

Glucose analyser IVD, home-use

• Primary Device ID: 20353885001285
• NIH Device Record Key: 9f87326d-f63e-4beb-bc26-1323a4324151
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OneTouch Ultramini
• Version Model Number: 021-419
• Catalog Number: 021-419
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00353885001281 [Primary]
GS1	20353885001285 [Package]; Contains: 00353885001281; Package: Shipper case [4 Units]; In Commercial Distribution
NDC/NHRIC	53885-419-01 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061118

FDA Product Code

• NBW: SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

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 Ultramini]

• 20353885011468: OneTouch Ultramini Blood Glucose Monitoring Meter - Warranty replacement
• 20353885008161: OneTouch Ultramini Blood Glucose Monitoring Meter - Warranty replacement
• 20353885008130: OneTouch Ultramini Blood Glucose Monitoring Meter - Warranty replacement
• 20353885002688: OneTouch Ultramini Blood Glucose Monitoring System with Delica Lancing Device, not for resale or
• 20353885002671: OneTouch Ultramini Blood Glucose Monitoring System with Delica Lancing Device. Uses OneTouch Ult
• 20353885001315: OneTouch Ultramini Blood Glucose Monitoring System with Delica Lancing Device, not for resale or
• 20353885001285: OneTouch Ultramini Blood Glucose Monitoring System with Delica Lancing Device. Uses OneTouch Ult
• 20353885000516: OneTouch Ultramini Blood Glucose Monitoring System with Delica Lancing Device, not for resale or
• 20353885000486: OneTouch Ultramini Blood Glucose Monitoring System with Delica Lancing Device, not for resale or