ClearSteth

Basic Information

• Brand Name: ClearSteth
• Primary DI: 00850033167108
• Version / Model: GSW30100103
• Catalog Number: GSW30100103
• Company Name: GLOBALMEDIA GROUP, LLC
• Labeler DUNS: 103201849
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-08
• Public Version: 1
• Public Version Date: 2023-12-18
• Public Version Status: New
• Public Device Record Key: 0cbf95b0-ef69-4fe2-adbd-02c9e7a16074

Device Description

Digital stethoscope and hosted software application solution.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DQD	Stethoscope, Electronic	Cardiovascular	870.1875	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41177	Stethoscope application software	A data application program designed for use in, or together with, a computer, e.g., a standard personal computer (PC), and an electronic stethoscope. This software program will permit, e.g., the visualization of the sound picture which can be used for enhanced diagnostic purposes.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850033167108	GS1

Premarket Submissions

Submission Number	Supplement Number
K081032	000