ClearSteth GSW30100103

GUDID 00850033167108

Digital stethoscope and hosted software application solution.

GLOBALMEDIA GROUP, LLC

Stethoscope application software Stethoscope application software Stethoscope application software Stethoscope application software Stethoscope application software Stethoscope application software Stethoscope application software Stethoscope application software Stethoscope application software Stethoscope application software Stethoscope application software Stethoscope application software Stethoscope application software Stethoscope application software Stethoscope application software 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