Patient Monitor V10 V10M-2PXNRU

GUDID 18800003407740

The V10 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diastolic and mean arterial pressures, functional arterial oxygen saturation (SpO2), pulse rate (PR), 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 V10 is suitable for continuous operation.

Mediana.CO.LTD

Single-patient intensive/general healthcare physiologic monitoring system

• Primary Device ID: 18800003407740
• NIH Device Record Key: 7b372977-d93e-496e-9d4b-8c48e714f118
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Patient Monitor V10
• Version Model Number: V10
• Catalog Number: V10M-2PXNRU
• 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	18800003407740 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170497

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

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: 2019-02-01

On-Brand Devices [Patient Monitor V10]

• 18800003408891: The V10 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diastoli
• 18800003408884: V10: The V10 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, dia
• 18800003408693: The V10 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diastoli
• 18800003408686: The V10 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diastoli
• 18800003408495: The V10 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diastoli
• 18800003408488: The V10 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diastoli
• 18800003407795: The V10 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diastoli
• 18800003407788: The V10 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diastoli
• 18800003407757: The V10 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diastoli
• 18800003407740: The V10 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diastoli