Stethee Pro Central Web Application

GUDID 09351356000055

Stethee Pro Central Web Application is a component of the Stethee Pro Software System. The Stethee Pro Software System is intended for use with the Stethee Pro Electronic Stethoscope.

M3DICINE PTY LTD

Phonocardiograph Phonocardiograph Phonocardiograph Phonocardiograph Phonocardiograph Phonocardiograph Phonocardiograph Phonocardiograph Phonocardiograph Phonocardiograph Phonocardiograph Phonocardiograph Phonocardiograph Phonocardiograph Phonocardiograph Phonocardiograph Phonocardiograph Phonocardiograph Phonocardiograph Phonocardiograph Phonocardiograph Phonocardiograph Phonocardiograph Phonocardiograph Phonocardiograph Phonocardiograph Phonocardiograph Phonocardiograph Phonocardiograph Phonocardiograph Phonocardiograph Phonocardiograph

• Primary Device ID: 09351356000055
• NIH Device Record Key: 3207b18e-8b8a-43e0-b48c-adb26c0260b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stethee Pro Central Web Application
• Version Model Number: 2.0.X
• Company DUNS: 757852710
• Company Name: M3DICINE PTY LTD
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09351356000055 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193631

FDA Product Code

• DQC: Phonocardiograph

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: 2020-12-31
• Device Publish Date: 2020-12-23

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• 09351356000055 - Stethee Pro Central Web Application: 2020-12-31Stethee Pro Central Web Application is a component of the Stethee Pro Software System. The Stethee Pro Software System is intended for use with the Stethee Pro Electronic Stethoscope.
• 09351356000055 - Stethee Pro Central Web Application: 2020-12-31 Stethee Pro Central Web Application is a component of the Stethee Pro Software System. The Stethee Pro Software System is intend
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