AccessGUDID - DEVICE: Tyto Insights for Wheeze Detection (07290016672725)

GUDID

Device Identifier (DI) Information

Brand Name: Tyto Insights for Wheeze Detection
Version or Model: Tyto Insights for Wheeze Detection _US
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: TYTO CARE LTD

Primary DI Number: 07290016672725
Issuing Agency: GS1
Commercial Distribution End Date: May 14, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 649125325 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
13754	Electronic acoustic stethoscope	An external, hand-held, electronic listening device designed to be used by a healthcare professional for real-time detection and amplification of body sounds (e.g., heart, blood vessels, lungs) that may be difficult to perceive when using a mechanical stethoscope; it is not designed for electrocardiography (ECG). It is typically designed to be connected to a computing device, which may operate interpretive software sometimes provided with the stethoscope, for recording and/or displaying the results in the form of a graph [phonocardiogram (PCG)].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PHZ	Abnormal Breath Sound Device

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K221614	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 85c65477-bb5c-400e-a628-ad09db8a834f
Public Version Date: November 25, 2024
Public Version Number: 3
DI Record Publish Date: May 14, 2023