Nonagon - The Nonagon N9 device is a home use device. The - NONAGON LTD

Duns Number:532283903

Device Description: The Nonagon N9 device is a home use device. The device is comprised of a handheld unit tha

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

MHD-100-02-001

Brand Name

Nonagon

Version/Model Number

N9

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K202483,K202483

Product Code Details

Product Code

DQA

Product Code Name

Oximeter

Device Record Status

Public Device Record Key

c455faa5-308b-4a6b-8f58-2685a4c56fff

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

May 26, 2021

Additional Identifiers

Package DI Number

17290018446109

Quantity per Package

1

Contains DI Package

07290018446102

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"NONAGON LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3