Product Overview

Base VITALOJAK
VitaloJAK - 7100


Device Description

An assembly of devices intended for 24-hour detection and recording of the number of times a patient coughs during daily activities or sleep, typically in the assessment of patients affected by various disorders associated with coughing (e.g., asthma, COPD). It typically consists of body-worn microphones and acoustic sensors designed to detect coughing sounds, and a small battery-powered portable recorder for registering the data. The recorded data is typically downloaded for analysis at a medical facility.


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: DSH

Device Name: Recorder, Magnetic Tape, Medical

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: Y

Medical Specialty: CV


Device Identifiers

Device Id: 05099169715110

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 15099169715117

Package Quantity: 1

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: N/A


Device Id: 15099169715117

Device Type: Primary

DeviceId Issuing Agency: GS1

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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