Insertion Kit with 6” (15cm) Introducer for use with MEGA 8Fr. 50cc IAB 0884-00-0019-17

GUDID 10607567107493

Insertion Kit with 6” (15cm) Introducer for use with MEGA 8Fr. 50cc IAB

DATASCOPE CORP.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 10607567107493
• NIH Device Record Key: 8d942858-bc0a-4a99-ad7e-187c64e45cd0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Insertion Kit with 6” (15cm) Introducer for use with MEGA 8Fr. 50cc IAB
• Version Model Number: 0884-00-0019-17
• Catalog Number: 0884-00-0019-17
• 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
• 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
• Catheter Gauge: 8 French
• Catheter Gauge: 8 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	10607567107493 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133074

FDA Product Code

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

Sterilization

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

[10607567107493]

Ethylene Oxide

[10607567107493]

Ethylene Oxide

[10607567107493]

Ethylene Oxide

[10607567107493]

Ethylene Oxide

[10607567107493]

Ethylene Oxide

[10607567107493]

Ethylene Oxide

[10607567107493]

Ethylene Oxide

[10607567107493]

Ethylene Oxide

[10607567107493]

Ethylene Oxide

[10607567107493]

Ethylene Oxide

[10607567107493]

Ethylene Oxide

[10607567107493]

Ethylene Oxide

[10607567107493]

Ethylene Oxide

[10607567107493]

Ethylene Oxide

[10607567107493]

Ethylene Oxide

[10607567107493]

Ethylene Oxide

[10607567107493]

Ethylene Oxide

[10607567107493]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-06-07
• Device Publish Date: 2016-09-16

On-Brand Devices [Insertion Kit with 6” (15cm) Introducer for use with MEGA 8Fr. 50cc IAB]

• 10607567107493: Insertion Kit with 6” (15cm) Introducer for use with MEGA 8Fr. 50cc IAB
• 10607567114217: Insertion Kit with 6” (15cm) Introducer for use with MEGA 8Fr. 50cc IAB