Hummingbird® H310

GUDID 00851680007168

H310 Hummingbird Tunneled Ventricular Catheter Kit

INNERSPACE NEURO SOLUTIONS, INC.

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 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: 00851680007168
• NIH Device Record Key: e004c14f-5b25-4672-b457-a1aec6e4e5be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hummingbird®
• Version Model Number: H310
• Catalog Number: H310
• Company DUNS: 080333634
• Company Name: INNERSPACE NEURO SOLUTIONS, INC.
• 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: 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: 877.486.2473
• Email: customerservice@hummingbirdneuro.com
• Phone: 877.486.2473
• Email: customerservice@hummingbirdneuro.com
• Phone: 877.486.2473
• Email: customerservice@hummingbirdneuro.com
• Phone: 877.486.2473
• Email: customerservice@hummingbirdneuro.com
• Phone: 877.486.2473
• Email: customerservice@hummingbirdneuro.com
• Phone: 877.486.2473
• Email: customerservice@hummingbirdneuro.com
• Phone: 877.486.2473
• Email: customerservice@hummingbirdneuro.com
• Phone: 877.486.2473
• Email: customerservice@hummingbirdneuro.com
• Phone: 877.486.2473
• Email: customerservice@hummingbirdneuro.com
• Phone: 877.486.2473
• Email: customerservice@hummingbirdneuro.com
• Phone: 877.486.2473
• Email: customerservice@hummingbirdneuro.com
• Phone: 877.486.2473
• Email: customerservice@hummingbirdneuro.com
• Phone: 877.486.2473
• Email: customerservice@hummingbirdneuro.com
• Phone: 877.486.2473
• Email: customerservice@hummingbirdneuro.com
• Phone: 877.486.2473
• Email: customerservice@hummingbirdneuro.com
• Phone: 877.486.2473
• Email: customerservice@hummingbirdneuro.com
• Phone: 877.486.2473
• Email: customerservice@hummingbirdneuro.com
• Phone: 877.486.2473
• Email: customerservice@hummingbirdneuro.com
• Phone: 877.486.2473
• Email: customerservice@hummingbirdneuro.com
• Phone: 877.486.2473
• Email: customerservice@hummingbirdneuro.com
• Phone: 877.486.2473
• Email: customerservice@hummingbirdneuro.com
• Phone: 877.486.2473
• Email: customerservice@hummingbirdneuro.com
• Phone: 877.486.2473
• Email: customerservice@hummingbirdneuro.com
• Phone: 877.486.2473
• Email: customerservice@hummingbirdneuro.com
• Phone: 877.486.2473
• Email: customerservice@hummingbirdneuro.com
• Phone: 877.486.2473
• Email: customerservice@hummingbirdneuro.com
• Phone: 877.486.2473
• Email: customerservice@hummingbirdneuro.com
• Phone: 877.486.2473
• Email: customerservice@hummingbirdneuro.com
• Phone: 877.486.2473
• Email: customerservice@hummingbirdneuro.com
• Phone: 877.486.2473
• Email: customerservice@hummingbirdneuro.com
• Phone: 877.486.2473
• Email: customerservice@hummingbirdneuro.com
• Phone: 877.486.2473
• Email: customerservice@hummingbirdneuro.com
• Phone: 877.486.2473
• Email: customerservice@hummingbirdneuro.com
• Phone: 877.486.2473
• Email: customerservice@hummingbirdneuro.com
• Phone: 877.486.2473
• Email: customerservice@hummingbirdneuro.com
• Phone: 877.486.2473
• Email: customerservice@hummingbirdneuro.com
• Phone: 877.486.2473
• Email: customerservice@hummingbirdneuro.com
• Phone: 877.486.2473
• Email: customerservice@hummingbirdneuro.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

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851680007168 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013705

FDA Product Code

• GWM: Device, Monitoring, Intracranial Pressure

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-28

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• 00851680007168: H310 Hummingbird Tunneled Ventricular Catheter Kit
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