Power Link B05033

GUDID 15099590583996

Power Link

Beckman Coulter, Inc.

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: 15099590583996
• NIH Device Record Key: fedb895d-6f9e-4cee-925f-b001ebe0bec0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Power Link
• Version Model Number: Power Link
• Catalog Number: B05033
• 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: false
• 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

Operating and Storage Conditions

• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 64.4 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 64.4 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 64.4 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 64.4 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 64.4 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 64.4 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 64.4 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 64.4 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 64.4 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 64.4 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 64.4 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 64.4 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 64.4 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 64.4 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 64.4 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 64.4 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	15099590583996 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110413

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-15

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