Hummingbird® H310

GUDID 00851680007168

H310 Hummingbird Tunneled Ventricular Catheter Kit

INNERSPACE NEURO SOLUTIONS, INC.

Intracerebral sensor catheter

• 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

On-Brand Devices [Hummingbird®]

• 00851680007205: H610 Hummingbird SynergyDuo Ventricular Catheter Kit
• 00851680007199: STC - Skull Thickness Caliper
• 00851680007182: H610MR Hummingbird SynergyDuo Ventricular Catheter Kit
• 00851680007175: H110MR Hummingbird Parenchymal Catheter Kit
• 00851680007168: H310 Hummingbird Tunneled Ventricular Catheter Kit
• 00851680007151: Hummingbird ICP Control Module with Patient Cable Module