CONNEQT PULSE

GUDID 19351315000086

The device is a non-invasive blood pressure measurement system that provides a derived ascending aortic blood pressure waveform and a range of central arterial indices. These measurements are provided non-invasively using a technique in which an inflatable cuff is wrapped around the upper arm. Additionally, the CONNEQT PULSE automatically provides brachial systolic and diastolic blood pressures and heart rate. The measurement range of the cuff circumference is 12.6’’- 16.5’’(32cm-42cm).

ATCOR MEDICAL PTY LTD

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 19351315000086
• NIH Device Record Key: d289c20d-2cb0-45f6-aee1-b6343e293f95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CONNEQT PULSE
• Version Model Number: BPM1AT
• Company DUNS: 751626706
• Company Name: ATCOR MEDICAL PTY 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	19351315000086 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221742

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-04
• Device Publish Date: 2025-08-27

On-Brand Devices [CONNEQT PULSE ]

• 19351315000086: The device is a non-invasive blood pressure measurement system that provides a derived ascending
• 19351315000062: CONNEQT PULSE is a non-invasive blood pressure measurement system that provides a derived ascend