CAMINO® CAM02

GUDID 10381780039310

Intracranial Pressure and Temperature Monitor

NATUS MEDICAL INCORPORATED

Intracranial pressure monitor Intracranial pressure monitor Intracranial pressure monitor Intracranial pressure monitor Intracranial pressure monitor Intracranial pressure monitor Intracranial pressure monitor Intracranial pressure monitor Intracranial pressure monitor

• Primary Device ID: 10381780039310
• NIH Device Record Key: 55154b00-a64a-4bfa-85e6-36fed201d3b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAMINO®
• Version Model Number: CAM02
• Catalog Number: CAM02
• Company DUNS: 081325959
• Company Name: NATUS MEDICAL INCORPORATED
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -20°C to +50°C; Relative Humidity, non-condensing: +25% to +80%; Atmospheric Pressure: +500hP0 to +1060hPa
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -20°C to +50°C; Relative Humidity, non-condensing: +25% to +80%; Atmospheric Pressure: +500hP0 to +1060hPa
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -20°C to +50°C; Relative Humidity, non-condensing: +25% to +80%; Atmospheric Pressure: +500hP0 to +1060hPa
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -20°C to +50°C; Relative Humidity, non-condensing: +25% to +80%; Atmospheric Pressure: +500hP0 to +1060hPa
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -20°C to +50°C; Relative Humidity, non-condensing: +25% to +80%; Atmospheric Pressure: +500hP0 to +1060hPa
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -20°C to +50°C; Relative Humidity, non-condensing: +25% to +80%; Atmospheric Pressure: +500hP0 to +1060hPa
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -20°C to +50°C; Relative Humidity, non-condensing: +25% to +80%; Atmospheric Pressure: +500hP0 to +1060hPa
• Special Storage Condition, Specify: Between 0 and 0 *Temperature: -20°C to +50°C; Relative Humidity, non-condensing: +25% to +80%; Atmospheric Pressure: +500hP0 to +1060hPa

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382830049023 [Primary]
GS1	10381780039310 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121573

FDA Product Code

• GWM: Device, Monitoring, Intracranial Pressure

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-05-06
• Device Publish Date: 2019-06-28

On-Brand Devices [CAMINO®]

• 10381780023661: CAMINO INTRCRANIAL PRESSURE MONITORING CATHETER WITH LICOX IMC BOLT FITTING
• 00382830047531: MICRO VENTRICULAR BOLT PRESSURE-TEMPERATURE MONITORING KIT
• 10381780258049: MICRO VENTRICULAR BOLT PRESSURE MONITORING KIT
• 10381780025511: POST CRANIOTOMY SUBDURAL PRESSURE MONITORING KIT
• 10381780023630: INTRACRANIAL PRESSURE-TEMPERATURE MONITORING KIT
• 10381780023623: OLM INTRACRANIAL PRESSURE MONITORING KIT
• 10381780039310: Intracranial Pressure and Temperature Monitor
• 10381780039570: Patient Monitor Cable
• 10381780121879: 18 V DC 1.67 A, 30 W AC Power Adapter
• 10381780121886: USB-to-RS232 Adapter Cable
• 10381780040965: Camino Flex Extension Cable
• 10381780039556: Fiber Optic Catheter Cable
• 00382830058049: Camino Flex Ventricular Intracranial Pressure Monitoring Kit
• 00382830048866: 14.4 V Lithium Ion Battery