MEGA 8Fr. 50cc IAB (with APA) 0684-00-0498-02

GUDID 10607567107318

MEGA 8Fr. 50cc IAB (with APA)

DATASCOPE CORP.

Intra-aortic balloon catheter

• Primary Device ID: 10607567107318
• NIH Device Record Key: d12ae095-4168-4441-bd20-0b0b1e6d817a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEGA 8Fr. 50cc IAB (with APA)
• Version Model Number: 0684-00-0498-02
• Catalog Number: 0684-00-0498-02
• Company DUNS: 001660786
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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

Device Dimensions

• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	10607567107318 [Primary]

FDA Product Code

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

Sterilization

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

[10607567107318]

Ethylene Oxide

[10607567107318]

Ethylene Oxide

[10607567107318]

Ethylene Oxide

[10607567107318]

Ethylene Oxide

[10607567107318]

Ethylene Oxide

[10607567107318]

Ethylene Oxide

[10607567107318]

Ethylene Oxide

[10607567107318]

Ethylene Oxide

[10607567107318]

Ethylene Oxide

[10607567107318]

Ethylene Oxide

[10607567107318]

Ethylene Oxide

[10607567107318]

Ethylene Oxide

[10607567107318]

Ethylene Oxide

[10607567107318]

Ethylene Oxide

[10607567107318]

Ethylene Oxide

[10607567107318]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-12-09
• Device Publish Date: 2016-09-15

Devices Manufactured by DATASCOPE CORP.

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• 10607567108001 - MEGA 8Fr. 50cc IAB (with Statlock): 2024-12-09 MEGA 8Fr. 50cc IAB (with Statlock)
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• 10607567108063 - SENSATION PLUS 7.5Fr. 40cc IAB & Accessories: 2024-12-09 SENSATION PLUS 7.5Fr. 40cc IAB & Accessories
• 10607567108605 - SENSATION PLUS 8Fr. 50cc IAB & Accessories (w/Pressure Tubes, No Stylet): 2024-12-09 SENSATION PLUS 8Fr. 50cc IAB & Accessories (w/Pressure Tubes, No Stylet)