Licox®

Primary DI
M273PMOBOX1
Brand
Licox®
Company
GMS, Gesellschaft für medizinische Sondentechnik mbH
Model
PMOBOX
Catalog number
PMOBOX
Device description
Licox® PMO Brain Oxygen Monitoring Interface Device
Published
2017-10-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
K040235000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040235000LICOX PMO BRAIN MONITORING SYSTEMIntegra LifeSciences Corporation2004-04-20GWM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780041399PrimaryGS10
M273PMOBOX1SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178004139910381780041399

GMDN Terms#

Term, Definition table
TermDefinition
Intracranial pressure monitorAn electrically-powered device intended for intermittent or continuous measurement and display of intracranial pressure (ICP). It is used in conjunction with an invasive intracranial device (e.g., intracerebral sensor catheter) that transmits electrical signals via connected cables or pressure signals via tubing (e.g., via the air pouch method). It may include an alarm designed to alert clinical staff to an elevated ICP and may also produce a strip-chart recording or display of the ICP waveform that enables interpretation of long-term ICP trends.

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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850013266272IRRAflow Cranial Access BoltClearpoint Neuro, Inc.GWM2025-07-24
00763000281243Exacta Pole Clamp with laser levelMEDTRONIC PS MEDICAL, INC.GWM2025-02-17
00763000281229Exacta Pole Clamp with laser levelMEDTRONIC PS MEDICAL, INC.GWM2025-02-16
00763000467401NAMEDTRONIC PS MEDICAL, INC.GWM2024-06-01
00763000406073BeckerMEDTRONIC PS MEDICAL, INC.GWM2024-03-31
20763000467344NAMEDTRONIC PS MEDICAL, INC.GWM2024-03-01
20763000467351NAMEDTRONIC PS MEDICAL, INC.GWM2024-02-26
20763000467382NAMEDTRONIC PS MEDICAL, INC.GWM2024-02-26
20763000467399NAMEDTRONIC PS MEDICAL, INC.GWM2024-02-26
00763000406080NAMEDTRONIC PS MEDICAL, INC.GWM2024-02-26
00763000431259BeckerMEDTRONIC PS MEDICAL, INC.GWM2024-02-26
00763000529307BeckerMEDTRONIC PS MEDICAL, INC.GWM2024-02-26
00763000529369BeckerMEDTRONIC PS MEDICAL, INC.GWM2024-02-26
00763000572877BeckerMEDTRONIC PS MEDICAL, INC.GWM2024-02-25
00850013266203IRRAflow Tube SetClearpoint Neuro, Inc.GWM2023-11-02
00763000624774Duet®MEDTRONIC PS MEDICAL, INC.GWM2022-03-10
00763000624781Duet®MEDTRONIC PS MEDICAL, INC.GWM2022-03-10
00763000624798Duet®MEDTRONIC PS MEDICAL, INC.GWM2022-03-10
00763000428723Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-03-07
00763000428747Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-03-07
00763000428754Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-03-07
00763000428761Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-03-07
00763000428778Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-03-07
00763000431273Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-02-13
20763000431307N/AMEDTRONIC PS MEDICAL, INC.GWM2021-02-07
00763000395971Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-02-07
00763000395988N/AMEDTRONIC PS MEDICAL, INC.GWM2021-02-07
00763000406004Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-02-07
00763000406011Duet®MEDTRONIC PS MEDICAL, INC.GWM2021-02-07