HOLTER CONNECT Relay Application is a software that is installed on a compatible commercially available platform (mobile or tablet) that manages secured wireless communication between the Biosensor and the HOLTER CONNECT Secure Server for transferring acquired ECG data by the Biosensor.


Product Overview

HOLTER CONNECT Relay Application is a software that is installed on a compatible commercially available platform (mobile or tablet) that manages secured wireless communication between the Biosensor and the HOLTER CONNECT Secure Server for transferring acquired ECG data by the Biosensor.
HOLTER CONNECT - LA1252R


Device Description

A mobile electronic device/device assembly designed to be used by a healthcare professional (e.g., nurse, caregiver) to capture patient physiological parameters from wireless patient measuring devices (e.g., wireless pulse oximeter, wireless thermometer) during routine patient checks (e.g., as part of nursing rounds) and wirelessly send the information to the electronic health record. It is intended to capture and transfer patient identification and time/date with the physiological data; it will typically in addition allow for manual entry of data. It typically includes a display monitor, wireless receivers, and barcode reader.


Environmental Conditions

No Data Available


Device Sizes

No Data Available


Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available


Product Codes

Code: DRG

Device Name: Transmitters And Receivers, Physiological Signal, Radiofrequency

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 870.2910

Third Party Flag: Y

Medical Specialty: CV


Code: MWJ

Device Name: Electrocardiograph, Ambulatory (Without Analysis)

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 870.2800

Third Party Flag: N

Medical Specialty: CV


Device Identifiers

Device Id: B353LA1252R1

Device Type: Primary

DeviceId Issuing Agency: HIBCC

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A


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