Direct Supply V10D-3XBCZU

GUDID 18800003439437

The AVSM2 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 AVSM2 is suitable for continuous operation.

Mediana.CO.LTD

Single-patient intensive/general healthcare physiologic monitoring system

• Primary Device ID: 18800003439437
• NIH Device Record Key: 10c67abe-278a-4694-a3f1-1ee7436250b8
• Commercial Distribution Discontinuation: 2018-01-25
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Direct Supply
• Version Model Number: AVSM2
• Catalog Number: V10D-3XBCZU
• 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	18800003439437 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170497

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: 2018-01-23

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