Hummingbird® SynergyDuo H610

GUDID 10850013266026

H610 Hummingbird SynergyDuo Ventricular Catheter Tray

IRRAS USA

Intracerebral sensor catheter

• 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
• 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
• 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

[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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