Hummingbird® SynergyDuo H610

GUDID 10850013266026

H610 Hummingbird SynergyDuo Ventricular Catheter Tray

IRRAS USA

Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter Intracerebral sensor catheter, short-term Intracerebral sensor catheter, short-term Intracerebral sensor catheter, short-term Intracerebral sensor catheter, short-term Intracerebral sensor catheter, short-term Intracerebral sensor catheter, short-term Intracerebral sensor catheter, short-term

• Primary Device ID: 10850013266026
• NIH Device Record Key: fffef5ba-2b67-449b-b2aa-7aae3dba1be2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hummingbird® SynergyDuo
• Version Model Number: H610
• Catalog Number: H610
• Company DUNS: 056999617
• Company Name: IRRAS USA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: 800-213-4604
• Email: info@irras.com
• Phone: 800-213-4604
• Email: info@irras.com
• Phone: 800-213-4604
• Email: info@irras.com
• Phone: 800-213-4604
• Email: info@irras.com
• Phone: 800-213-4604
• Email: info@irras.com
• Phone: 800-213-4604
• Email: info@irras.com
• Phone: 800-213-4604
• Email: info@irras.com
• Phone: 800-213-4604
• Email: info@irras.com
• Phone: 800-213-4604
• Email: info@irras.com
• Phone: 800-213-4604
• Email: info@irras.com
• Phone: 800-213-4604
• Email: info@irras.com
• Phone: 800-213-4604
• Email: info@irras.com
• Phone: 800-213-4604
• Email: info@irras.com
• Phone: 800-213-4604
• Email: info@irras.com
• Phone: 800-213-4604
• Email: info@irras.com
• Phone: 800-213-4604
• Email: info@irras.com
• Phone: 800-213-4604
• Email: info@irras.com
• Phone: 800-213-4604
• Email: info@irras.com
• Phone: 800-213-4604
• Email: info@irras.com
• Phone: 800-213-4604
• Email: info@irras.com
• Phone: 800-213-4604
• Email: info@irras.com
• Phone: 800-213-4604
• Email: info@irras.com
• Phone: 800-213-4604
• Email: info@irras.com

Device Dimensions

• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French
• Catheter Gauge: 8.5 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850013266029 [Primary]
GS1	10850013266026 [Package]; Contains: 00850013266029; Package: Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083378

FDA Product Code

• GWM: Device, Monitoring, Intracranial Pressure

Sterilization

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

[10850013266026]

Ethylene Oxide

[10850013266026]

Ethylene Oxide

[10850013266026]

Ethylene Oxide

[10850013266026]

Ethylene Oxide

[10850013266026]

Ethylene Oxide

[10850013266026]

Ethylene Oxide

[10850013266026]

Ethylene Oxide

[10850013266026]

Ethylene Oxide

[10850013266026]

Ethylene Oxide

[10850013266026]

Ethylene Oxide

[10850013266026]

Ethylene Oxide

[10850013266026]

Ethylene Oxide

[10850013266026]

Ethylene Oxide

[10850013266026]

Ethylene Oxide

[10850013266026]

Ethylene Oxide

[10850013266026]

Ethylene Oxide

[10850013266026]

Ethylene Oxide

[10850013266026]

Ethylene Oxide

[10850013266026]

Ethylene Oxide

[10850013266026]

Ethylene Oxide

[10850013266026]

Ethylene Oxide

[10850013266026]

Ethylene Oxide

[10850013266026]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-18
• Device Publish Date: 2019-10-10

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• 10850013266200 - IRRAflow Tube Set: 2023-11-10
• 10850013266231 - Hummingbird: 2023-10-23 IC 40 Cranial Access Kit
• 10850013266248 - Hummingbird: 2023-10-23 IC42 Cranial Access Kit
• 00850013266104 - Hummingbird® HICP200 Monitor Interconnect Cable - Spacelabs 6 Pin Monitor: 2022-06-10 Hummingbird® HICP200 Monitor Interconnect Cable - Spacelabs 6 Pin Monitor
• 10850013266019 - Hummingbird® Patient Monitor: 2020-05-06 HICP200 Hummingbird Patient / Monitor Interconnect Cable
• 10868643000477 - IRRAflow® Drainage Collection System: 2020-05-06 DCS 010 Drainage Collection System