AccessGUDID - DEVICE: Camino® (10381780121893)

GUDID

Device Identifier (DI) Information

Brand Name: Camino®
Version or Model: BAT1001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: INTEGRA LIFESCIENCES (IRELAND) LIMITED

Primary DI Number: 10381780121893
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: Use only Integra-supplied 14.4 V lithium ion battery for LICOX and CAMINO monitors. Charge time = No more than 5 hours, while the monitor is plugged into an AC power outlet and the monitor is turned off. Operation time = 1.5 hours.

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":	No
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?
36534	Portable/mobile rechargeable battery pack	A group of rechargeable batteries held within a holder, container, or mobile cart/trolley intended to provide temporary electrical energy to operate a medical device, typically when it is not possible, intentional, or convenient to connect the device being powered to a mains electricity (AC-powered) electrical outlet; it might additionally have features to facilitate transport of the device being powered (e.g., push handles, storage shelves, mounting rails). It is typically used during a transport situation (e.g., a neonatal incubator) or to power a cordless device (e.g., an endoscopic device or a rechargeable battery-powered surgical drilling system handpiece). 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 [?]
Premarket Submission Number Not Available/Not Released

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: -20°C to +50°C; Relative Humidity, non-condensing: +25% to +80%; Atmospheric Pressure: +500hP0 to +1060hPa

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 5h Charge Time, 1.5h Operation time

Device Record Status

Public Device Record Key: cf1a6fc5-3f67-4191-9821-cc9f80ebe246
Public Version Date: April 14, 2025
Public Version Number: 8
DI Record Publish Date: December 29, 2016