Nonagon MHD-100-02-001

GUDID 07290018446102

The Nonagon N9 device is a home use device. The device is comprised of a handheld unit that connects with a smartphone and a dedicated smartphone software application that runs on the user's personal smartphone An API is defined to enable healthcare providers to communicate with the device. The Device enables user’s examination at home with or without the guidance of a remote physician. It also enables guidance and data examination by a remote physician over an IP network. The Smartphone Application controls the Handheld Unit's functionality and processes and displays the collected data. The N9 device measure, record, and transmit data of auscultation sound of human body (lung, hear, abdomen), temperature, oxygen saturation (SpO2) and pulse rate, and can be used to send images of an examined body part. In addition, the device includes otoscope where images of the ear can be transmitted to the healthcare provider.

NONAGON LTD

Pulse oximeter, battery-powered

• Primary Device ID: 07290018446102
• NIH Device Record Key: c455faa5-308b-4a6b-8f58-2685a4c56fff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nonagon
• Version Model Number: N9
• Catalog Number: MHD-100-02-001
• Company DUNS: 532283903
• Company Name: NONAGON 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: true
• Manufacturing Date: true
• 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	07290018446102 [Primary]
GS1	17290018446109 [Package]; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202483

FDA Product Code

• DQA: Oximeter

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: 2021-06-03
• Device Publish Date: 2021-05-26

Devices Manufactured by NONAGON LTD

• 17290018446154 - Nonagon N9+: 2022-10-06
• 27290018446151 - Nonagon N9+ SmartExam: 2022-10-06
• 07290018446126 - N9 speculum: 2021-09-21 ENT ear speculum for Nonagon N9 device
• 07290018446102 - Nonagon: 2021-06-03The Nonagon N9 device is a home use device. The device is comprised of a handheld unit that connects with a smartphone and a dedicated smartphone software application that runs on the user's personal smartphone An API is defined to enable healthcare providers to communicate with the device. The Device enables user’s examination at home with or without the guidance of a remote physician. It also enables guidance and data examination by a remote physician over an IP network. The Smartphone Application controls the Handheld Unit's functionality and processes and displays the collected data. The N9 device measure, record, and transmit data of auscultation sound of human body (lung, hear, abdomen), temperature, oxygen saturation (SpO2) and pulse rate, and can be used to send images of an examined body part. In addition, the device includes otoscope where images of the ear can be transmitted to the healthcare provider.
• 07290018446102 - Nonagon: 2021-06-03 The Nonagon N9 device is a home use device. The device is comprised of a handheld unit that connects with a smartphone and a ded