CARDIOSAVE HYBRID, 3.1 EDITION 0998-00-0800-65

GUDID 10607567113432

CARDIOSAVE HYBRID, 3.1 EDITION

Datascope Corp.

Intra-aortic balloon pump

• Primary Device ID: 10607567113432
• NIH Device Record Key: 3c64fc90-60bc-4e69-93d0-40a0e1996ad0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CARDIOSAVE HYBRID, 3.1 EDITION
• Version Model Number: 0998-00-0800-65
• Catalog Number: 0998-00-0800-65
• 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

Operating and Storage Conditions

• Handling 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
• Handling 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
• Handling 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
• Handling 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
• Handling 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
• Handling 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
• Handling 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
• Handling 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
• Handling 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
• Handling 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
• Handling 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
• Handling 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
• Handling 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10607567113432 [Primary]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-17
• Device Publish Date: 2024-09-09

Devices Manufactured by Datascope Corp.

• 10607567113432 - CARDIOSAVE HYBRID, 3.1 EDITION: 2024-09-17CARDIOSAVE HYBRID, 3.1 EDITION
• 10607567113432 - CARDIOSAVE HYBRID, 3.1 EDITION: 2024-09-17 CARDIOSAVE HYBRID, 3.1 EDITION
• 10607567113449 - CARDIOSAVE RESCUE, 3.1 EDITION: 2024-09-17 CARDIOSAVE RESCUE, 3.1 EDITION
• 10607567114187 - CARDIOSAVE HYBRID - TYPE "N" PLUG: 2024-09-17 CARDIOSAVE HYBRID - TYPE "N" PLUG
• 10607567107585 - YAMATO PLUS-R 30cc IAB WITH ACCESSORIES AND RETRACTION KIT: 2024-08-20 YAMATO PLUS-R 30cc IAB WITH ACCESSORIES AND RETRACTION KIT
• 10607567107592 - YAMATO PLUS-R 30cc IAB WITH ACCESSORIES AND RETRACTION KIT (APA): 2024-08-20 YAMATO PLUS-R 30cc IAB WITH ACCESSORIES AND RETRACTION KIT (APA)
• 10607567107608 - YAMATO PLUS-R 35cc IAB WITH ACCESSORIES AND RETRACTION KIT: 2024-08-20 YAMATO PLUS-R 35cc IAB WITH ACCESSORIES AND RETRACTION KIT
• 10607567107639 - YAMATO PLUS-R 40cc IAB WITH ACCESSORIES AND RETRACTION KIT (APA): 2024-08-20 YAMATO PLUS-R 40cc IAB WITH ACCESSORIES AND RETRACTION KIT (APA)
• 10607567111537 - Catheter Extender for Yamato Plus IABs - 10 Pack: 2024-08-20 Catheter Extender for Yamato Plus IABs - 10 Pack