OneTouch Ultra 021-416

GUDID 20353885006235

One Touch Ultra Control Solution

LifeScan Europe GmbH

Glucose monitoring system IVD, point-of-care

• Primary Device ID: 20353885006235
• NIH Device Record Key: 1bd4c6a5-b0d8-4939-b9b1-a68945194379
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OneTouch Ultra
• Version Model Number: 021-416
• Catalog Number: 021-416
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00353885006231 [Primary]
GS1	20353885006235 [Package]; Contains: 00353885006231; Package: Shipper case [48 Units]; In Commercial Distribution
NDC/NHRIC	53885-937-01 [Secondary]

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: 2019-12-03
• Device Publish Date: 2019-11-25

On-Brand Devices [OneTouch Ultra]

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