Nonagon N9+

GUDID 17290018446154

NONAGON LTD

Pulse oximeter
Primary Device ID17290018446154
NIH Device Record Keybd3f8e36-f166-4851-aaa7-d8354223347c
Commercial Distribution StatusIn Commercial Distribution
Brand NameNonagon N9+
Version Model NumberN9+
Company DUNS532283903
Company NameNONAGON LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS117290018446154 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQDStethoscope, Electronic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-06
Device Publish Date2022-09-28

Devices Manufactured by NONAGON LTD

17290018446154 - Nonagon N9+2022-10-06
17290018446154 - Nonagon N9+2022-10-06
27290018446151 - Nonagon N9+ SmartExam2022-10-06
07290018446126 - N9 speculum2021-09-21 ENT ear speculum for Nonagon N9 device
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

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