Integra® Camino®

Primary DI
M273VTUNCATHETER0
Brand
Integra® Camino®
Company
GMS, Gesellschaft für medizinische Sondentechnik mbH
Model
VTUN-Catheter
Catalog number
VTUN-Catheter
Device description
Integra® Camino® Flex Ventricular Intracranial Pressure Monitoring Catheter
Published
2015-10-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

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
K133754000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133754000INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH FLEX ADAPTERIntegra LifeSciences Corporation2014-03-06GWM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780041450PrimaryGS10
M273VTUNCATHETER0SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178004145010381780041450

GMDN Terms#

Term, Definition table
TermDefinition
Intracerebral sensor catheterA sterile flexible tube with a sensor at the distal end intended to be surgically inserted through the skull for short-term (= 30 days) access to the ventricular and/or parenchymal areas of the brain to drain cerebrospinal fluid (CSF) and to measure intracranial parameters [e.g., intracranial pressure (ICP), temperature, partial pressure of oxygen (pO2)]; it may also be intended for infusion of materials (e.g., chemotherapeutic agents, radioisotopes). It may include accessory devices intended to facilitate catheter introduction, stabilization, and/or fluid collection/infusion (e.g., stylet, bolts, drills, drainage/infusion port/reservoir). This is a single-use device.

Device Sizes#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315902197
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780041078Licox®CC1P1CC1P12015-10-01
10381780041122Licox®IP1IP12015-10-01
10381780041139Licox®IP2IP22015-10-01
10381780041184Licox®IP1PIP1P2015-10-01
10381780041191Licox®IP2PIP2P2015-10-01
10381780041221Licox®BC10PMOBC10PMO2015-10-01
10381780041399Licox®PMOBOXPMOBOX2017-10-09
10381780041405Licox®PMOCABPMOCAB2015-10-01
10381780041412Licox®PMOFCPMOFC2017-10-09
10381780041429Licox®PMOPSTPMOPST2017-10-09
10381780041436Licox®VK52VK522015-10-01
M273IP11Licox®IP1IP12015-10-01
M273IP21Licox®IP2IP22015-10-01
M273BC10PMO0Licox®BC10PMOBC10PMO2015-10-01
M273PMOCAB0Licox®PMOCABPMOCAB2015-10-01
M273PMOFC0Licox®PMOFCPMOFC2017-10-09
M273PMOPST0Licox®PMOPSTPMOPST2017-10-09
10381780041108Licox®IM2IM22015-10-01
10381780041115Licox®IM3IM32015-10-01
10381780041153Licox®IM2SIM2S2015-10-01

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20763000431307N/AMEDTRONIC PS MEDICAL, INC.GWM2021-02-07
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