Direct Supply PA3DS-B0

GUDID 18800003400567

The purpose and function of the Direct Supply Attendant Vital Signs Monitor AVM-1 is to monitor non-invasive blood pressure (systolic, diastolic, and mean arterial pressures), functional arterial oxygen saturation, pulse rate and temperature for adult patients in all hospital areas, and hospital-type facilities. It may be used during hospital transport and in mobile, land-based environments, such as ambulances, within the specification of the environmental characteristics.

Mediana.CO.LTD

Single-patient intensive/general healthcare physiologic monitoring system 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: 18800003400567
• NIH Device Record Key: 0a8af805-c722-499f-bd8d-6e669705d392
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Direct Supply
• Version Model Number: AVM-1
• Catalog Number: PA3DS-B0
• 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	18800003400567 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051375

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-06
• Device Publish Date: 2016-09-26

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