AU

GUDID 15099590131180

SYSTEM CALIBRATOR

BECKMAN COULTER IRELAND INC.

Multiple clinical chemistry analyte IVD, calibrator

• Primary Device ID: 15099590131180
• NIH Device Record Key: 124b7448-b430-4816-a2cc-e50224e4437f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AU
• Version Model Number: 66300
• Company DUNS: 985071975
• Company Name: BECKMAN COULTER IRELAND 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	15099590131180 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141388

FDA Product Code

• JIX: Calibrator, Multi-Analyte Mixture

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: 2016-09-24

On-Brand Devices [AU]

• 15099590666361: Urine CSF Albumin Calibrator
• 15099590635602: Lyophilized Chemistry Calibrator Level 1
• 15099590635572: Lyophilized Chemistry Calibrator Level 2
• 15099590131180: SYSTEM CALIBRATOR
• 15099590070441: BICARBONATE CALIBRATOR
• 15099590012120: HbA1c Advanced
• 15099590010645: MICROALBUMIN
• 15099590010607: α-1 ANTITRYPSIN
• 15099590010591: α-1 Acidglycoprotein