Stethee Pro Mobile iOS Application

GUDID 09351356000048

Stethee Pro Mobile iOS 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

• Primary Device ID: 09351356000048
• NIH Device Record Key: 6e24a754-e1cc-4886-aafd-b433cfd7b332
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Stethee Pro Mobile iOS 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	09351356000048 [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

Devices Manufactured by M3DICINE PTY LTD

• 09351356000031 - Stethee Pro Mobile Android Application: 2020-12-31 Stethee Pro Mobile Android Application is a component of the Stethee Pro Software System. The Stethee Pro Software System is in
• 09351356000048 - Stethee Pro Mobile iOS Application: 2020-12-31Stethee Pro Mobile iOS 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.
• 09351356000048 - Stethee Pro Mobile iOS Application: 2020-12-31 Stethee Pro Mobile iOS Application is a component of the Stethee Pro Software System. The Stethee Pro Software System is intend
• 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
• 09351356000017 - Stethee Pro: 2020-05-06 The Stethee™ Pro 1 is an electronic stethoscope intended for medical diagnostic purposes only. It may be used for the detecti