Power Link B05033

GUDID 15099590583996

Power Link

Beckman Coulter, Inc.

Specimen processing instrument IVD, automated

• 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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