Licox® PMOBOX

GUDID M273PMOBOX1

Licox® PMO Brain Oxygen Monitoring Interface Device

GMS, Gesellschaft für medizinische Sondentechnik mbH

Intracranial pressure monitor

• Primary Device ID: M273PMOBOX1
• NIH Device Record Key: a1bae26e-d2f3-4396-84e7-89f82fa5b324
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Licox®
• Version Model Number: PMOBOX
• Catalog Number: PMOBOX
• Company DUNS: 315902197
• Company Name: GMS, Gesellschaft für medizinische Sondentechnik mbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780041399 [Primary]
HIBCC	M273PMOBOX1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040235

FDA Product Code

• GWM: DEVICE, MONITORING, INTRACRANIAL PRESSURE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-05-06
• Device Publish Date: 2017-10-09

On-Brand Devices [Licox®]

• M273PMOBOX1: Licox® PMO Brain Oxygen Monitoring Interface Device
• M273A10US1: Licox® CMP Mains Power Supply
• M273IT21: Licox® Complete Brain Tunnelling Probe Kit
• M273IP2P1: Licox® Complete Brain Probe Kit
• M273IP1P1: Licox® Complete Brain Probe Kit
• M273IM3ST1: Licox® Complete Brain Probe Kit
• M273IM3S1: Licox® Complete Brain Probe Kit
• M273IM2S1: Licox® Complete Brain Probe Kit
• M273IM1S1: Licox® Complete Brain Probe Kit
• M273C8B1: Licox® Temperature Probe
• M273CC1P11: Licox® Combined Oxygen and Temperature Probe
• M273CC1SB1: Licox® Oxygen Probe
• M273VK521: Licox® Parenchymal Probe Guide
• M273IM31: Licox® Triple Lumen Introducer Kit
• M273IM21: Licox® Dual Lumen Introducer Kit