BPro BT Ambulatory Blood Pressure Monitoring System

Basic Information

• Brand Name: BPro BT Ambulatory Blood Pressure Monitoring System
• Primary DI: 08885014410098
• Version / Model: T6200 series
• Company Name: HEALTHSTATS INTERNATIONAL PTE LTD
• Labeler DUNS: 628476459
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-14
• Public Version: 3
• Public Version Date: 2021-04-07
• Public Version Status: Update
• Public Device Record Key: 95ba5ad2-5e35-4f77-87b4-746bbc78d75f

Device Description

The BPro® BT Ambulatory Blood Pressure Monitoring system is a noninvasive ambulatoryblood pressure monitoring system based on arterial tonometry at the radial artery of the wrist with radial pulse waveform acquisition.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	870.1130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36888	Blood pressure ambulatory recorder	An electrically-powered, noninvasive device designed to be worn by a patient (typically on the arm or wrist) during daily activities for 24-hour recording of blood pressure; it is not intended to detect cardiac arrythmias. The recorded measurements can be downloaded and analysed at a medical facility, typically using a computer with a dedicated software. The device typically incorporates display and controls and may include a cuff with connection tubing and/or calibration device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08885014410098	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K173028	000