Ultimate 667730

GUDID 15099590223021

Ultimate -D Bilirubin Control Level 3

Beckman Coulter, Inc.

Total bilirubin IVD, control

• Primary Device ID: 15099590223021
• NIH Device Record Key: 81b340af-abd2-423b-874f-f0530ba62e67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultimate
• Version Model Number: 667730
• Catalog Number: 667730
• 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	15099590223021 [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