Ultimate 667720

GUDID 15099590223038

Ultimate -D Bilirubin Control Level 2

Beckman Coulter, Inc.

Total bilirubin IVD, control Total bilirubin IVD, control Total bilirubin IVD, control Total bilirubin IVD, control Total bilirubin IVD, control Total bilirubin IVD, control Total bilirubin IVD, control Total bilirubin IVD, control Total bilirubin IVD, control Total bilirubin IVD, control Total bilirubin IVD, control Total bilirubin IVD, control Total bilirubin IVD, control Total bilirubin IVD, control Total bilirubin IVD, control Total bilirubin IVD, control Total bilirubin IVD, control Total bilirubin IVD, control Total bilirubin IVD, control

• Primary Device ID: 15099590223038
• NIH Device Record Key: c4430c6e-d337-4971-be5e-a2f491f875c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultimate
• Version Model Number: 667720
• Catalog Number: 667720
• Company DUNS: 008254708
• Company Name: Beckman Coulter, Inc.
• 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	15099590223038 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K802068

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-24

On-Brand Devices [Ultimate]

• 15099590228705: Ultimate -D Bilirubin Control Level 1
• 15099590223038: Ultimate -D Bilirubin Control Level 2
• 15099590223021: Ultimate -D Bilirubin Control Level 3
• 15099590223014: Ultimate -D Bilirubin Control Level 4