OneTouch Ultra 010-458

GUDID 20353885458027

One Touch Ultra Control Solution

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

• Primary Device ID: 20353885458027
• NIH Device Record Key: b47b12ae-dee3-4ef9-9815-71aadd1f496f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OneTouch Ultra
• Version Model Number: 010-458
• Catalog Number: 010-458
• Company DUNS: 480240820
• Company Name: LifeScan Europe GmbH
• Device Count: 150
• 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: false
• 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

Customer Support Contacts

• Phone: +1 8002278862
• Email: XX@XX.XX
• Phone: +1 8002278862
• Email: XX@XX.XX
• Phone: +1 8002278862
• Email: XX@XX.XX
• Phone: +1 8002278862
• Email: XX@XX.XX
• Phone: +1 8002278862
• Email: XX@XX.XX
• Phone: +1 8002278862
• Email: XX@XX.XX
• Phone: +1 8002278862
• Email: XX@XX.XX
• Phone: +1 8002278862
• Email: XX@XX.XX
• Phone: +1 8002278862
• Email: XX@XX.XX
• Phone: +1 8002278862
• Email: XX@XX.XX
• Phone: +1 8002278862
• Email: XX@XX.XX
• Phone: +1 8002278862
• Email: XX@XX.XX
• Phone: +1 8002278862
• Email: XX@XX.XX
• Phone: +1 8002278862
• Email: XX@XX.XX

Device Identifiers

Device Issuing Agency	Device ID
GS1	00353885458023 [Primary]
GS1	20353885458027 [Package]; Contains: 00353885458023; Package: Shipper case [48 Units]; In Commercial Distribution
NDC/NHRIC	53885-458-02 [Secondary]
GS1	80353885458029 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103553

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

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: 2020-08-10
• Device Publish Date: 2020-07-31

On-Brand Devices [OneTouch Ultra]

• 20353885006235: One Touch Ultra Control Solution
• 20353885458027: One Touch Ultra Control Solution