OneTouch Ultra

GUDID 20353885013004

LIFESCAN, INC.

Glucose IVD, kit, electrometry

• Primary Device ID: 20353885013004
• NIH Device Record Key: 41d38192-ce21-420b-a854-e58822952023
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OneTouch Ultra
• Version Model Number: 024-391
• Company DUNS: 153409313
• Company Name: LIFESCAN, INC.
• Device Count: 30
• 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: false
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *do not refrigerate
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *do not refrigerate
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *do not refrigerate
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *do not refrigerate
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *do not refrigerate
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *do not refrigerate
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *do not refrigerate
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *do not refrigerate
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *do not refrigerate
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *do not refrigerate
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *do not refrigerate
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *do not refrigerate
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *do not refrigerate
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *do not refrigerate
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *do not refrigerate
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *do not refrigerate
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *do not refrigerate
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *do not refrigerate
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *do not refrigerate
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *do not refrigerate
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *do not refrigerate
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *do not refrigerate
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *do not refrigerate
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *do not refrigerate
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *do not refrigerate
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00353885013000 [Primary]
GS1	20353885013004 [Package]; Contains: 00353885013000; Package: [24 Units]; In Commercial Distribution
GS1	80353885013006 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053529

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-30
• Device Publish Date: 2025-06-20

Devices Manufactured by LIFESCAN, INC.

• 20353885013004 - OneTouch Ultra: 2025-06-30
• 20353885013004 - OneTouch Ultra: 2025-06-30
• 20353885012656 - OneTouch Ultra Blue Test Strips: 2022-08-05 OneTouch Ultra Test Strips Blue for blood glucose testing with: OneTouch Ultra 2, OneTouch UltraMini, OneTouch Ultra, OneTouch U