BPro® Ambulatory Blood Pressure Monitoring System

GUDID 08885014410012

BPro® Ambulatory Blood Pressure Monitoring System is a noninvasive ambulatory blood pressure monitoring (ABPM) system based on arterial tonometry at the radial artery and oscillometry at the upper arm. It is used for measuring systolic pressure, diastolic pressure and pulse rate of adults.

HEALTHSTATS INTERNATIONAL PTE LTD

Blood pressure ambulatory recorder

• Primary Device ID: 08885014410012
• NIH Device Record Key: 428c9559-a74e-46a1-91b9-772931199036
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BPro® Ambulatory Blood Pressure Monitoring System
• 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: true
• 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: +65686583248
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• Phone: +65686583248
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• Phone: +65686583248
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• Phone: +65686583248
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• Phone: +65686583248
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• Phone: +65686583248
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• Phone: +65686583248
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• Phone: +65686583248
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• Phone: +65686583248
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• Phone: +65686583248
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• Phone: +65686583248
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• Phone: +65686583248
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• Phone: +65686583248
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• Phone: +65686583248
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• Phone: +65686583248
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• Phone: +65686583248
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• Phone: +65686583248
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• Phone: +65686583248
• Email: xxx@xx.xx
• Phone: +65686583248
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• Phone: +65686583248
• Email: xxx@xx.xx
• Phone: +65686583248
• Email: xxx@xx.xx
• Phone: +65686583248
• Email: xxx@xx.xx
• Phone: +65686583248
• Email: xxx@xx.xx
• Phone: +65686583248
• Email: xxx@xx.xx
• Phone: +65686583248
• Email: xxx@xx.xx
• Phone: +65686583248
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• Phone: +65686583248
• Email: xxx@xx.xx
• Phone: +65686583248
• Email: xxx@xx.xx
• Phone: +65686583248
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• Phone: +65686583248
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• Phone: +65686583248
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• Phone: +65686583248
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• Phone: +65686583248
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• Phone: +65686583248
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• Phone: +65686583248
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• Phone: +65686583248
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• Phone: +65686583248
• Email: xxx@xx.xx
• Phone: +65686583248
• Email: xxx@xx.xx
• Phone: +65686583248
• Email: xxx@xx.xx
• Phone: +65686583248
• Email: xxx@xx.xx
• Phone: +65686583248
• Email: xxx@xx.xx
• Phone: +65686583248
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Device Identifiers

Device Issuing Agency	Device ID
GS1	08885014410012 [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: 2016-09-20

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: 2019-11-08BPro® Ambulatory Blood Pressure Monitoring System is a noninvasive ambulatory blood pressure monitoring (ABPM) system based on arterial tonometry at the radial artery and oscillometry at the upper arm. It is used for measuring systolic pressure, diastolic pressure and pulse rate of adults.
• 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