Tyto Insights for Wheeze Detection

GUDID 07290016672725

The Insights for Wheeze Detection is an over-the-counter decision support software system used in the evaluation of lung sounds in adults and children (2 years and older). It automatically analyzes the acoustic signal of the lung as recorded by the FDA cleared compatible Tyto Stethoscope and identifies recordings where a specific abnormal lung sound suggestive of “Wheeze” is suspected. It is not intended to detect other abnormal or normal lung sounds. A licensed health care professional’s advice is required to understand the meaning of the Tyto Insights for Wheeze Detection result. Healthcare provider should consider the device result in conjunction with recording and other relevant patient data.

TYTO CARE LTD

Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope Electronic stethoscope

• Primary Device ID: 07290016672725
• NIH Device Record Key: 85c65477-bb5c-400e-a628-ad09db8a834f
• Commercial Distribution Discontinuation: 2023-05-14
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Tyto Insights for Wheeze Detection
• Version Model Number: Tyto Insights for Wheeze Detection _US
• Company DUNS: 649125325
• Company Name: TYTO CARE 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016672725 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221614

FDA Product Code

• PHZ: Abnormal Breath Sound Device

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: 2023-05-22
• Device Publish Date: 2023-05-14

Devices Manufactured by TYTO CARE LTD

• 07290016672725 - Tyto Insights for Wheeze Detection: 2023-05-22The Insights for Wheeze Detection is an over-the-counter decision support software system used in the evaluation of lung sounds in adults and children (2 years and older). It automatically analyzes the acoustic signal of the lung as recorded by the FDA cleared compatible Tyto Stethoscope and identifies recordings where a specific abnormal lung sound suggestive of “Wheeze” is suspected. It is not intended to detect other abnormal or normal lung sounds. A licensed health care professional’s advice is required to understand the meaning of the Tyto Insights for Wheeze Detection result. Healthcare provider should consider the device result in conjunction with recording and other relevant patient data.
• 07290016672725 - Tyto Insights for Wheeze Detection: 2023-05-22 The Insights for Wheeze Detection is an over-the-counter decision support software system used in the evaluation of lung sounds
• 17290016672685 - TytoHome: 2022-05-19 TytoHome used for comprehensive remote exam and telehealth. This is a convenience kit containing the following DIs: 072900166724
• 07290016672473 - Tyto Device: 2020-12-17 The Tyto Device unit contains the Tyto Exam Camera and Tyto Thermometer. It is used also as the display (UI) and operation comp
• 17290016672487 - TytoHome: 2020-12-17 TytoHome used for comprehensive remote exam and telehealth. This is a convenience kit containing the following DIs: 072900166724
• 17290016672531 - Tyto Device: 2020-12-17 The Tyto Device G2 unit contains the Tyto Exam Camera and Tyto Thermometer. It is used also as the display (UI) and operation co
• 07290016672541 - TytoPro: 2020-12-17 Designed for professional use, TytoPro used for comprehensive remote exam and telehealth. The TytoPro includes the Tyto Otoscope
• 07290016672404 - Tyto Stethoscope: 2020-10-19 The Tyto Stethoscope is an electronic stethoscope that enables transmission of auscultation sound data, whereby a clinician at o
• 07290016672411 - Tyto Otoscope: 2020-10-19 The Tyto Otoscope is an electronic otoscope that enables capturing and transmission of video and still images of the external ea