A-PULSE CASPal® Central Aortic Systolic Pressure Monitoring Device

GUDID 08885014410050

The A-PULSE CASPal® is a noninvasive blood pressure monitoring system which is designed to measure the Central Aortic Systolic Pressure (CASP) based on arterial tonometry at the radial artery of the wrist.

HEALTHSTATS INTERNATIONAL PTE LTD

Blood pressure ambulatory recorder

• Primary Device ID: 08885014410050
• NIH Device Record Key: 37a3425e-8695-4b4d-a04a-36943b91f36d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: A-PULSE CASPal® Central Aortic Systolic Pressure Monitoring Device
• Version Model Number: T7200 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
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• Phone: +6568583248
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• Phone: +6568583248
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• Phone: +6568583248
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• Phone: +6568583248
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• Phone: +6568583248
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• Phone: +6568583248
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• Phone: +6568583248
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• Phone: +6568583248
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• Phone: +6568583248
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• Phone: +6568583248
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• Phone: +6568583248
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• Phone: +6568583248
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• Phone: +6568583248
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• Phone: +6568583248
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• Phone: +6568583248
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• Phone: +6568583248
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• Phone: +6568583248
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• Phone: +6568583248
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• Phone: +6568583248
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• Phone: +6568583248
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• Phone: +6568583248
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• Phone: +6568583248
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• Phone: +6568583248
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• Phone: +6568583248
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• Phone: +6568583248
• Email: xxx@xx.xx
• Phone: +6568583248
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• Phone: +6568583248
• Email: xxx@xx.xx
• Phone: +6568583248
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• Phone: +6568583248
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• Phone: +6568583248
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• Phone: +6568583248
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• Phone: +6568583248
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• Phone: +6568583248
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• 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
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Device Identifiers

Device Issuing Agency	Device ID
GS1	08885014410050 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101002

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: 2019-11-08The A-PULSE CASPal® is a noninvasive blood pressure monitoring system which is designed to measure the Central Aortic Systolic Pressure (CASP) based on arterial tonometry at the radial artery of the wrist.
• 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