DxA 5000

GUDID 15099590707118

DxA 5000

Beckman Coulter, Inc.

Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD

• Primary Device ID: 15099590707118
• NIH Device Record Key: 1018fb63-2c68-4fdb-9a84-4bba2fc15a61
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DxA 5000
• Version Model Number: DxA 5000
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15099590707118 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190298

FDA Product Code

• JJE: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

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: 2019-11-12
• Device Publish Date: 2019-11-04

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