CS100 Intra-Aortic Balloon Pump, English, 220V 0998-00-3013-55

GUDID 10607567107295

CS100 Intra-Aortic Balloon Pump, English, 220V

Datascope Corp.

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• Primary Device ID: 10607567107295
• NIH Device Record Key: fcc73632-d1b7-446e-911a-3c99693dbc02
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CS100 Intra-Aortic Balloon Pump, English, 220V
• Version Model Number: 0998-00-3013-55
• Catalog Number: 0998-00-3013-55
• Company DUNS: 040874329
• Company Name: Datascope Corp.
• 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: 888-627-8383
• Email: customer.support@maquet.com
• Phone: 888-627-8383
• Email: customer.support@maquet.com
• Phone: 888-627-8383
• Email: customer.support@maquet.com
• Phone: 888-627-8383
• Email: customer.support@maquet.com
• Phone: 888-627-8383
• Email: customer.support@maquet.com
• Phone: 888-627-8383
• Email: customer.support@maquet.com
• Phone: 888-627-8383
• Email: customer.support@maquet.com
• Phone: 888-627-8383
• Email: customer.support@maquet.com
• Phone: 888-627-8383
• Email: customer.support@maquet.com
• Phone: 888-627-8383
• Email: customer.support@maquet.com
• Phone: 888-627-8383
• Email: customer.support@maquet.com
• Phone: 888-627-8383
• Email: customer.support@maquet.com
• Phone: 888-627-8383
• Email: customer.support@maquet.com
• Phone: 888-627-8383
• Email: customer.support@maquet.com
• Phone: 888-627-8383
• Email: customer.support@maquet.com
• Phone: 888-627-8383
• Email: customer.support@maquet.com
• Phone: 888-627-8383
• Email: customer.support@maquet.com
• Phone: 888-627-8383
• Email: customer.support@maquet.com
• Phone: 888-627-8383
• Email: customer.support@maquet.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 483 Millimeter of Mercury and 760 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 483 Millimeter of Mercury and 760 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 483 Millimeter of Mercury and 760 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 483 Millimeter of Mercury and 760 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 483 Millimeter of Mercury and 760 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 483 Millimeter of Mercury and 760 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 483 Millimeter of Mercury and 760 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 483 Millimeter of Mercury and 760 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 483 Millimeter of Mercury and 760 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 483 Millimeter of Mercury and 760 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 483 Millimeter of Mercury and 760 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 483 Millimeter of Mercury and 760 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 483 Millimeter of Mercury and 760 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 483 Millimeter of Mercury and 760 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 483 Millimeter of Mercury and 760 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 483 Millimeter of Mercury and 760 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 483 Millimeter of Mercury and 760 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 483 Millimeter of Mercury and 760 Millimeter of Mercury
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10607567107295 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031636

FDA Product Code

• DSP: System, Balloon, Intra-Aortic And Control

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-05-06
• Device Publish Date: 2016-09-21

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