ClearSteth GSW30100103

GUDID 00850033167108

Digital stethoscope and hosted software application solution.

GLOBALMEDIA GROUP, LLC

Stethoscope application software

• Primary Device ID: 00850033167108
• NIH Device Record Key: 0cbf95b0-ef69-4fe2-adbd-02c9e7a16074
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ClearSteth
• Version Model Number: GSW30100103
• Catalog Number: GSW30100103
• Company DUNS: 103201849
• Company Name: GLOBALMEDIA GROUP, LLC
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850033167108 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081032

FDA Product Code

• DQD: Stethoscope, Electronic

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: 2023-12-18
• Device Publish Date: 2023-12-08

Devices Manufactured by GLOBALMEDIA GROUP, LLC

• 00850033167115 - eNcounter: 2023-12-20 A complete telehealth platform that offers secure telemedicine software solutions with diagnostic and clinical workflow capabili
• 00850033167108 - ClearSteth: 2023-12-18Digital stethoscope and hosted software application solution.
• 00850033167108 - ClearSteth: 2023-12-18 Digital stethoscope and hosted software application solution.
• 00850033167122 - Variable Polarizing Hood: 2023-12-18 An instrument that eliminates unwanted glare from surfaces that are being examined.
• 00850033167139 - First Exam Station: 2023-12-18 Videoconferencing cart
• 00850033167146 - Total Vitals: 2023-12-18 The All-in-One Health Monitor is a device designed for measuring the patient’s physiological parameters, such as Non-Invasive
• 00850033167153 - Total Vitals: 2023-12-18 The All-in-One Health Monitor is a device designed for measuring the patient’s physiological parameters, such as Non-Invasive
• 00850033167160 - Total Vitals: 2023-12-18 The All-in-One Health Monitor is a device designed for measuring the patient’s physiological parameters, such as Non-Invasive
• 00850033167177 - Total ECG: 2023-12-18 ECG device incorporating a wireless 12-Lead ECG system, Windows®-based CardioVu software using the Glasgow 12-lead ECG analysis