FDA.reportPublic FDA data

Camino®

Primary DI
M273CAM021
Brand
Camino®
Company
INTEGRA LIFESCIENCES (IRELAND) LIMITED
Model
CAM02
Device description
The Integra Camino ICP Monitor is a compact, portable device that provides tools for continuously determining and monitoring intracranial pressure (ICP) and intracranial temperature (ICT) directly in the brain, depending on which catheters are connected to the system. This monitor supports Integra Camino Fiber Optic Catheters for measuring both ICP and temperature, and Integra Camino Flex Catheter for measuring ICP values.
Published
2016-12-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWMDEVICE, MONITORING, INTRACRANIAL PRESSURE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWMDevice, Monitoring, Intracranial PressureNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121573000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121573000INTEGRA CAMINO ICP MONITORIntrgra Lifesciences Corporation2012-09-10GWM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780039310PrimaryGS10
M273CAM021SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178003931010381780039310

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Temperature: -20°C to +50°C; Relative Humidity, non-condensing: +25% to +80%; Atmospheric Pressure: +500hP0 to +1060hPa

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
989925396
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780039570Camino®PMIOMPM1PMIOMPM-12016-12-29
10381780533870CUSA® ClarityC7404SC7404S2023-06-21
10381780533894CUSA® ClarityC7404LSC7404LS2023-06-21
10381780536369CUSA® ClarityC7421SC7421S2022-11-15
10381780536383CUSA® ClarityC7523XC7523X2023-07-14
10381780536376CUSA® ClarityC7523XEAC7523XEA2023-07-14
10381780536352CUSA® ClarityC7421SEAC7421SEA2022-11-15
10381780533863CUSA® ClarityC7404SEAC7404SEA2022-09-06
10381780533887CUSA® ClarityC7404LSEAC7404LSEA2022-09-06
10381780026075CUSA® ExcelC4616SC4616S2016-12-29
10381780026082CUSA® ExcelC4617SC4617S2016-12-29
10381780248248CUSA® ExcelC4604ELTUS2016-12-29
10381780031659CUSA® ExcelC4617SEAC4617SEA2016-12-29
10381780466291Integra®PMIOMPM-1PMIOMPM-12018-05-30
10381780250074Licox®BC10PMOBC10PMO2016-08-02
10381780250043Licox®PMOCABPMOCAB2016-08-02
10381780121893Camino®BAT10012016-12-29
10381780039556Camino®CAMCABL2016-12-29
10381780121886Camino®EXPORTCABEXPORTCAB2016-12-29
10381780121879Camino®MONPWRMONPWR2016-12-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03701813000023Catheter Extension CableSOPHYSAGWM2026-10-27
03701813000030PRESSIO® 3 - PATIENT MONITOR EXTENSION CABLE - 3 PARAMETERS (ICP, ICT, MAP)SOPHYSAGWM2026-10-27
03701813000054Catheter Extension CableSOPHYSAGWM2026-10-27
03760409441510PRESSIO® 3 - PATIENT MONITOR EXTENSION CABLE - 3 PARAMETERS (ICP, ICT, MAP)SOPHYSAGWM2026-10-27
03760409441527PRESSIO®3 - PATIENT MONITOR CABLE PHILIPS, AGILENT, MINDRAY 12 pinsSOPHYSAGWM2026-10-27
03760409441534PRESSIO®3 - PATIENT MONITOR CABLE DRAEGER, SIEMENS 10 pinsSOPHYSAGWM2026-10-27
03760409441541PRESSIO®3 - PATIENT MONITOR CABLE SPACELAB, MINDRAY 6 pinsSOPHYSAGWM2026-10-27
03760409441558PRESSIO®3 - PATIENT MONITOR CABLE GE DATEX OHMEDA 10 pinsSOPHYSAGWM2026-10-27
03760409441565PRESSIO®3 - PATIENT MONITOR CABLE GE SOLAR, MARQUETTE 11 pinsSOPHYSAGWM2026-10-27
03760409441572PRESSIO®3 - PATIENT MONITOR CABLE NIHON KOHDEN 5 pinsSOPHYSAGWM2026-10-27
03760409441589PRESSIO®3 - TEMPERATURE PATIENT MONITOR CABLE PHILIPS, AGILENT 2 pinsSOPHYSAGWM2026-10-27
03760409441596PRESSIO®3 - TEMPERATURE PATIENT MONITOR CABLE DRAEGER, SIEMENS 7 pinsSOPHYSAGWM2026-10-27
03760409441602PRESSIO®3 - TEMPERATURE PATIENT MONITOR CABLE SPACELAB 10 pinsSOPHYSAGWM2026-10-27
03760409441619PRESSIO®3 - TEMPERATURE PATIENT MONITOR CABLE GE SOLAR, MARQUETTE, DATEX-OHMEDASOPHYSAGWM2026-10-27
03760409441626PRESSIO®3 - TEMPERATURE PATIENT MONITOR CABLE DATEX-OHMEDA, NIHON KOHDEN, MINDRASOPHYSAGWM2026-10-27
03760409441633PRESSIO®3 - TEMPERATURE PATIENT MONITOR CABLE ARTIC SUNSOPHYSAGWM2026-10-27
03760409441640PRESSIO®3 - ANALOG BLOOD PRESSURE CABLE PHILIPS Jack 3,5mmSOPHYSAGWM2026-10-27
03760409441657PRESSIO®3 - ANALOG BLOOD PRESSURE CABLE DRAEGER INFINITYSOPHYSAGWM2026-10-27
03760409441671PRESSIO®3 - ANALOG BLOOD PRESSURE CABLE GE without patient data moduleSOPHYSAGWM2026-10-27
03760409441688PRESSIO®3 - ANALOG BLOOD PRESSURE CABLE GE CARESCAPE & GE with patient data moduSOPHYSAGWM2026-10-27
03760409441695PRESSIO®3 - ANALOG BLOOD PRESSURE CABLE MINDRAY BENEVIEW T6 & UMEC SERIES 8, 10,SOPHYSAGWM2026-10-27
03760409441701PRESSIO®3 - ANALOG BLOOD PRESSURE CABLE MINDRAY PASSPORT 8, 12 & EPM 10, 12SOPHYSAGWM2026-10-27
03760409441718PRESSIO®3 - ANALOG BLOOD PRESSURE CABLE MINDRAY BENEVIEW N1, N12, N15, N17, N19,SOPHYSAGWM2026-10-27
03760409441725PRESSIO®3 - ANALOG BLOOD PRESSURE CABLE NIHON KOHDEN LIFE SCOPE PT, LIFE SCOPE VSOPHYSAGWM2026-10-27
03760409441732PRESSIO®3 - ANALOG BLOOD PRESSURE CABLE NIHON KOHDEN LIFE SCOPE PT with YJ-920PSOPHYSAGWM2026-10-27
03760409441749PRESSIO®3 - MULTI-PARAMETER NEUROMONITOR ICP, ICT, CPPSOPHYSAGWM2026-10-27
03760409442074PRESSIO®3 - PATIENT MONITOR CABLE SPACELAB 10 pinsSOPHYSAGWM2026-10-27
03760409442081PRESSIO®3 - PATIENT MONITOR CABLE NIHON KOHDEN 14 pinsSOPHYSAGWM2026-10-27
03760409442098PRESSIO®3 - PATIENT MONITOR CABLE FUKUDA DENSHI 12 pinsSOPHYSAGWM2026-10-27
03760409442104PRESSIO®3 - PATIENT MONITOR CABLE FUKUDA DENSHI 11 pinsSOPHYSAGWM2026-10-27