AccessGUDID - DEVICE: Camino® (10381780122012)

GUDID

Device Identifier (DI) Information

Brand Name: Camino®
Version or Model: FLEXADR
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: INTEGRA LIFESCIENCES (IRELAND) LIMITED

Primary DI Number: 10381780122012
Issuing Agency: GS1
Commercial Distribution End Date: April 01, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 989925396 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47487	Electrical-only medical device connection cable, reusable	A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GWM	DEVICE, MONITORING, INTRACRANIAL PRESSURE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K121159	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 150mm width x 350mm height x 30mm depth, 0.5kg (1.1lbs) weight

Device Record Status

Public Device Record Key: d48acb45-01a2-4746-8037-df729fbbd854
Public Version Date: April 06, 2020
Public Version Number: 4
DI Record Publish Date: December 29, 2016