BPro® Radial Pulse Wave Acquisition Device

GUDID 08885014410104

The BPro® device is designed to be worn like a wristwatch and to function as a blood pressure monitor.

HEALTHSTATS INTERNATIONAL PTE LTD

Blood pressure ambulatory recorder

• Primary Device ID: 08885014410104
• NIH Device Record Key: e352358b-83f1-4a1b-83d8-5b2569e160d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BPro® Radial Pulse Wave Acquisition Device
• Version Model Number: T6200 Series
• Company DUNS: 628476459
• Company Name: HEALTHSTATS INTERNATIONAL PTE LTD
• 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: false
• Serial Number: true
• Manufacturing Date: false
• 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: false

Customer Support Contacts

• Phone: +6568583248
• Email: xxx@xx.xx
• Phone: +6568583248
• Email: xxx@xx.xx
• Phone: +6568583248
• Email: xxx@xx.xx
• Phone: +6568583248
• Email: xxx@xx.xx
• Phone: +6568583248
• Email: xxx@xx.xx
• Phone: +6568583248
• Email: xxx@xx.xx
• Phone: +6568583248
• Email: xxx@xx.xx
• Phone: +6568583248
• Email: xxx@xx.xx
• Phone: +6568583248
• Email: xxx@xx.xx
• Phone: +6568583248
• Email: xxx@xx.xx
• Phone: +6568583248
• Email: xxx@xx.xx
• Phone: +6568583248
• Email: xxx@xx.xx
• Phone: +6568583248
• Email: xxx@xx.xx
• Phone: +6568583248
• Email: xxx@xx.xx
• Phone: +6568583248
• Email: xxx@xx.xx
• Phone: +6568583248
• Email: xxx@xx.xx
• Phone: +6568583248
• Email: xxx@xx.xx
• Phone: +6568583248
• Email: xxx@xx.xx
• Phone: +6568583248
• Email: xxx@xx.xx
• Phone: +6568583248
• Email: xxx@xx.xx
• Phone: +6568583248
• Email: xxx@xx.xx
• Phone: +6568583248
• Email: xxx@xx.xx
• Phone: +6568583248
• Email: xxx@xx.xx
• Phone: +6568583248
• Email: xxx@xx.xx
• Phone: +6568583248
• Email: xxx@xx.xx
• Phone: +6568583248
• Email: xxx@xx.xx
• Phone: +6568583248
• Email: xxx@xx.xx
• Phone: +6568583248
• Email: xxx@xx.xx
• Phone: +6568583248
• Email: xxx@xx.xx
• Phone: +6568583248
• Email: xxx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	08885014410104 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060315

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: 2019-11-08
• Device Publish Date: 2016-09-23

Devices Manufactured by HEALTHSTATS INTERNATIONAL PTE LTD

• 08885014410005 - BPro BT Radial Pulse Wave Acquisition Device: 2019-11-08 The BPro® BT is used to capture the pulse wave from the radial artery.
• 08885014410012 - BPro® Ambulatory Blood Pressure Monitoring System: 2019-11-08 BPro® Ambulatory Blood Pressure Monitoring System is a noninvasive ambulatory blood pressure monitoring (ABPM) system based on
• 08885014410029 - MC3100™ Oscillometric Blood Pressure Monitor: 2019-11-08 The MC3100™ is an oscillometric blood pressure monitor for measuring systolic pressure, diastolic pressure and pulse rate.
• 08885014410036 - A-PULSE CASP® Pulse Wave Analysis System: 2019-11-08 The A-PULSE CASP® pulse wave analysis system consists of the BPro® radial pulse wave acquisition device, a blood pressure (BP)
• 08885014410043 - A-PULSE CASPro® Central Aortic Systolic Pressure Monitoring Device(Professional): 2019-11-08 The A-PULSE CASPro® is a noninvasive blood pressure monitoring system designed to measure the Central Aortic Systolic Pressure
• 08885014410050 - A-PULSE CASPal® Central Aortic Systolic Pressure Monitoring Device: 2019-11-08 The A-PULSE CASPal® is a noninvasive blood pressure monitoring system which is designed to measure the Central Aortic Systolic
• 08885014410067 - MC3100™+ Oscillometric Blood Pressure Monitor: 2019-11-08 The MC3100™+ is a noninvasive blood pressure monitor for measuring the systolic pressure, diastolic pressure and pulse rate us
• 08885014410074 - A-PULSE CASPal®+ Central Aortic Systolic Pressure Monitoring Device: 2019-11-08 The A-PULSE CASPal®+ is a noninvasive blood pressure monitoring system which is designed to measure the Central Aortic Systolic