Camino®

GUDID 10381780122012

The Integra Camino Flex Adapter is designed as an accessory to connect the Integra Camino Flex Catheters (Integra LifeSciences Corporation) with the Camino Advanced Monitor (CAM01) for the direct and continuous measurement of intracranial pressure (ICP). It is a reusable device with an accessory holder which allows the Integra Camino Flex Adapter to be permanently attached to the Camino Advanced Monitor.

INTEGRA LIFESCIENCES (IRELAND) LIMITED

Electrical-only medical device connection cable, reusable

• Primary Device ID: 10381780122012
• NIH Device Record Key: d48acb45-01a2-4746-8037-df729fbbd854
• Commercial Distribution Discontinuation: 2020-04-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Camino®
• Version Model Number: FLEXADR
• Company DUNS: 989925396
• Company Name: INTEGRA LIFESCIENCES (IRELAND) LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Temperature: 0°C (+32°F) to +50°C (+122°F). Relative Humidity, non-condensing: +20% to +95%. Pressure: +500hPa to +1060hPa.

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780122012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121159

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: 4
• Public Version Date: 2020-04-06
• Device Publish Date: 2016-12-29

On-Brand Devices [Camino®]

• 10381780122012: The Integra Camino Flex Adapter is designed as an accessory to connect the Integra Camino Flex C
• M273FLEXEXT1: The Integra Camino Flex Extension Cable is used to connect the Integra Camino Flex Catheter to t
• 10381780039662: The AP adapter cable is a medical device accessory designed to support the interconnection of th
• 10381780039648: The AP adapter cable is a medical device accessory designed to support the interconnection of th
• 10381780039631: The AP adapter cable is a medical device accessory designed to support the interconnection of th
• 10381780039624: The AP adapter cable is a medical device accessory designed to support the interconnection of th
• 10381780039600: The AP adapter cable is a medical device accessory designed to support the interconnection of th
• 10381780039594: The AP adapter cable is a medical device accessory designed to support the interconnection of th
• M273CAMCABL1: The Integra Fiber Optic Catheter Cable (CAMCABL) is used to support the direct and continuous me
• M273CAM021: The Integra Camino ICP Monitor is a compact, portable device that provides tools for continuousl
• M273PAC11: The Integra PAC1 cable is intended for use with Camino CAM01 and MPM monitors and Camino Flex ca
• 10381780039754: The ICP adapter cable is a medical device accessory designed to support the interconnection of t
• 10381780039815: The ICT adaptor cable is a medical device accessory designed to support the interconnection of t
• 10381780039808: The ICT adaptor cable is a medical device accessory designed to support the interconnection of t
• 10381780039792: The ICP adapter cable is a medical device accessory designed to support the interconnection of t
• 10381780039785: The ICP adapter cable is a medical device accessory designed to support the interconnection of t
• 10381780039778: The ICP adapter cable is a medical device accessory designed to support the interconnection of t
• 10381780039761: The ICP adapter cable is a medical device accessory designed to support the interconnection of t
• 10381780039747: The ICP adapter cable is a medical device accessory designed to support the interconnection of t
• 10381780039730: The ICP adapter cable is a medical device accessory designed to support the interconnection of t
• 10381780039723: The ICP adapter cable is a medical device accessory designed to support the interconnection of t
• 10381780039716: The ICP adapter cable is a medical device accessory designed to support the interconnection of t
• 10381780039709: The ICP adapter cable is a medical device accessory designed to support the interconnection of t
• 10381780039693: The ICP adapter cable is a medical device accessory designed to support the interconnection of t
• 10381780039686: The ICP adapter cable is a medical device accessory designed to support the interconnection of t
• 10381780039679: The ICP adapter cable is a medical device accessory designed to support the interconnection of t
• M273PMIOSPM1: The Integra Camino Patient bedside monitoring cable (PMIOSPM) is intended to be used to interfac
• M273PAC21: The Integra PAC2 cable is intended for use with Single Parameter Monitor SPM to support the dire
• M273PMIOMPM11: The Integra Camino PMIOMPM-1 cables are accessories for the Integra Camino Monitor range MPM-1,
• 10381780039655: The AP adapter cable is a medical device accessory designed to support the interconnection of th
• 10381780039617: The AP adapter cable is a medical device accessory designed to support the interconnection of th