CAMINO® CAM02

GUDID 10381780039310

Intracranial Pressure and Temperature Monitor

NATUS MEDICAL INCORPORATED

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