Direct Supply AVSM3SNF-3XBNEU

GUDID 18800003465528

The V20, V20a, AVSM3 SNF are intended to be used to monitor noninvasive blood pressure(NIBP) - systolic, diastolic and mean arterial pressures, functional arterial oxygen saturation(SpO2), pulse rate (PR) and temperature (TEMP) 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 V20 and V20a are for adult, pediatric and neonatal patients and the AVSM3 SNF is for adult patients only. Also, the V20 is only suitable for single measurement but V20a and AVSM3 SNF are suitable for single as well as continuous measurement.

Mediana.CO.LTD

General-purpose multi-parameter bedside monitor

• Primary Device ID: 18800003465528
• NIH Device Record Key: ccfb6d32-3619-410d-a679-4172f81b7c7d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Direct Supply
• Version Model Number: AVSM3
• Catalog Number: AVSM3SNF-3XBNEU
• 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	18800003465528 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200434

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-28
• Device Publish Date: 2021-06-18

On-Brand Devices [Direct Supply]

• 18800003447494: The AVSM2 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diasto
• 18800003447487: The AVSM2 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diasto
• 18800003447470: The AVSM2 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diasto
• 18800003439444: The AVSM2 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diasto
• 18800003439437: The AVSM2 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diasto
• 18800003439420: The AVSM2 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diasto
• 18800003424990: The AVSM2 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diast
• 18800003424952: The AVSM2 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diasto
• 18800003424808: The AVSM2 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diast
• 18800003424792: The AVSM2 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diast
• 18800003424761: The AVSM2 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diasto
• 18800003424754: The AVSM2 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diasto
• 18800003400574: The purpose and function of the Direct Supply Attendant Vital Signs Monitor AVM-1 is to monitor
• 18800003400567: The purpose and function of the Direct Supply Attendant Vital Signs Monitor AVM-1 is to monitor
• 18800003456809: The AVSM2 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diast
• 18800003456847: The AVSM2 is intended to be used to monitor noninvasive blood pressure (NIBP) - systolic, diast
• 18800003460066: The V20, V20a, AVSM3 SNF are intended to be used to monitor noninvasive blood pressure(NIBP) - s
• 18800003465528: The V20, V20a, AVSM3 SNF are intended to be used to monitor noninvasive blood pressure(NIBP) - s
• 18800003465535: The V20, V20a, AVSM3 SNF are intended to be used to monitor noninvasive blood pressure(NIBP) - s