Blood pressure monitor

GUDID 04710953421161

The device is a arm type blood pressure monitor intended for automatically measures systolic and diastolic blood pressure and pulse rate by the oscillometric method. The measurement position is at the arm.The cuff circumference is limited to 220 mm - 420 mm (approx.:9 - 17 inches).The device is intended for home use. When the device detects irregular heart beats during measurement, an irregular heartbeat symbol will appear along with the measured readings

AVITA CORPORATION

Automatic-inflation electronic sphygmomanometer, non-portable

• Primary Device ID: 04710953421161
• NIH Device Record Key: a7622e3c-6c74-4958-98e9-fa0afcfc0476
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blood pressure monitor
• Version Model Number: BPA-O300
• Company DUNS: 658023275
• Company Name: AVITA CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +886285121568
• Email: steven_jhou@avita.com.tw

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	04710953421161 [Primary]
GS1	04710953421192 [Package]; Package: Cardboard box [24 Units]; In Commercial Distribution

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: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2018-08-12

On-Brand Devices [Blood pressure monitor]

• 04710953421161: The device is a arm type blood pressure monitor intended for automatically measures systolic and
• 04710953420942: The device is a wrist type blood pressure monitor intended for automatically measures systolic a