Patient Monitor M30 M30M-3PXAH

GUDID 18800003427847

M30 is intended to be used to monitor electrocardiography (ECG), heart rate (HR), noninvasive blood pressure (NIBP) - systolic, diastolic and mean arterial pressures, functional arterial oxygen saturation (SpO2), pulse rate (PR), respiration rate (RR), capnography (EtCO2 and InCO2) temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities. Monitor users should be skilled at the level of a technician, doctor, nurse or medical specialist. The M30 is suitable for continuous operation.

Mediana.CO.LTD

Single-patient intensive/general healthcare physiologic monitoring system General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor

• Primary Device ID: 18800003427847
• NIH Device Record Key: 9a015a27-fdc3-4006-90b9-451c096dd43c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Patient Monitor M30
• Version Model Number: M30
• Catalog Number: M30M-3PXAH
• Company DUNS: 687879726
• Company Name: Mediana.CO.LTD
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	18800003427847 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100217

FDA Product Code

• MHX: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-06
• Device Publish Date: 2019-08-08

On-Brand Devices [Patient Monitor M30]

• 18800003428929: The M30 is intended to be used to monitor electrocardiography (ECG), heart rate (HR), noninvasiv
• 18800003427847: M30 is intended to be used to monitor electrocardiography (ECG), heart rate (HR), noninvasive bl
• 18800003427205: The M30 is intended to be used to monitor electrocardiography (ECG), heart rate (HR), noninvasiv