CARDIOSAVE HYBRID TYPE I (AU) 0998-00-0800-31

GUDID 10607567109053

CARDIOSAVE HYBRID TYPE I (AU)

Datascope Corp.

Intra-aortic balloon pump

• Primary Device ID: 10607567109053
• NIH Device Record Key: 0deeeaa0-3736-4eae-b6a8-dfbe7dc19348
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CARDIOSAVE HYBRID TYPE I (AU)
• Version Model Number: 0998-00-0800-31
• Catalog Number: 0998-00-0800-31
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 483 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 483 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 483 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 483 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 483 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 483 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 483 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 483 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 483 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 483 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 483 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 483 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 483 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 483 Millimeter of Mercury and 795 Millimeter of Mercury
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10607567109053 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151254

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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