Nonagon

Primary DI
07290018446102
Brand
Nonagon
Company
NONAGON LTD
Model
N9
Catalog number
MHD-100-02-001
Device description
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.
Published
2021-05-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DQAOximeter
DQDStethoscope, Electronic
ERAOtoscope
FLLThermometer, Electronic, Clinical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2
DQDStethoscope, ElectronicCardiovascular2
ERAOtoscopeEar, Nose, Throat1
FLLContinuous Measurement ThermometerGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202483000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202483000MyHomeDocMyhomedoc , Ltd.2021-03-23DQD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290018446109PackageGS11In Commercial Distribution
07290018446102PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001844610917290018446109
07290018446102072900184461027290018446102

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter, battery-poweredA portable, battery-powered, photoelectric device intended for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals, typically produced by light-emitting diodes (LEDs) and a receiving detector in a probe, or directly built-in, are used to make the measurements using the principle of spectrophotometry. The oximeter displays the SpO2 values and may calculate/display other parameters, e.g., pulse rate, electrocardiogram (ECG). The device is typically applied to the fingertip or around the wrist; it may be used by healthcare facilities, emergency services, or in the home.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
532283903
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17290018446154Nonagon N9+N9+2022-09-28
27290018446151Nonagon N9+ SmartExamN9+2022-09-28
27290018446120N9 speculumN/AMHD-100-02-0332021-09-13
07290018446126N9 speculumN/AMHD-100-02-0332021-09-13

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