OneTouch Ultra Blue 020-963

GUDID 20353885004187

OneTouch Ultra Test Strips Blue for blood glucose testing with: OneTouch Ultra 2, OneTouch UltraMini, OneTouch Ultra, OneTouch UltraSmart, OneTouch Ping and OneTouch UltraLink Meters

LifeScan Europe GmbH

Glucose IVD, kit, electrometry

• Primary Device ID: 20353885004187
• NIH Device Record Key: eb86d4c4-9a92-4aa1-8054-64d3ab25d8a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OneTouch Ultra Blue
• Version Model Number: 020-963
• Catalog Number: 020-963
• Company DUNS: 480240820
• Company Name: LifeScan Europe GmbH
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• 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: +1(800)227-8862
• Email: XX@XX.XX

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00353885004183 [Primary]
GS1	20353885004187 [Package]; Contains: 00353885004183; Package: Shipper case [128 Units]; In Commercial Distribution
GS1	30353885004184 [Package]; Contains: 00353885004183; Package: Shipper case [240 Units]; In Commercial Distribution
NDC/NHRIC	53885-963-50 [Secondary]
GS1	80353885004189 [Unit of Use]

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 Ultra Blue]

• 20353885994259: OneTouch Ultra Test Strips Blue for blood glucose testing with: OneTouch Ultra 2, OneTouch Ultra
• 20353885011574: OneTouch Ultra Test Strips Blue for blood glucose testing with: OneTouch Ultra 2, OneTouch Ultra
• 20353885011567: OneTouch Ultra Test Strips Blue for blood glucose testing with: OneTouch Ultra 2, OneTouch Ultra
• 20353885009724: OneTouch Ultra Test Strips Blue for blood glucose testing with: OneTouch Ultra 2, OneTouch Ultra
• 20353885009717: OneTouch Ultra Test Strips Blue for blood glucose testing with: OneTouch Ultra 2, OneTouch Ultra
• 20353885004187: OneTouch Ultra Test Strips Blue for blood glucose testing with: OneTouch Ultra 2, OneTouch Ultra