FDA.reportPublic FDA data

Nox T3s System

Primary DI
15694311111467
Brand
Nox T3s System
Company
Nox Medical ehf.
Model
NOX-T3S_USF
Catalog number
511112
Published
2021-05-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQAOximeter
MNRVentilatory Effort Recorder

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2
MNRVentilatory Effort RecorderAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082113000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082113000NOX T3, NOXTURNAL (PC APPLICATION)Nox Medical2008-11-07MNR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15694311111467PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1569431111146715694311111467

GMDN Terms#

Term, Definition table
TermDefinition
Polysomnography analyserA mains electricity (AC-powered) device designed to record and interpret a variety of physiologic functions during sleep to evaluate sleep/sleep-related disorders (e.g., insomnia, hypersomnia, apnoea). It typically performs electroencephalography, electrocardiography, electro-oculography, electromyography, and respiration, temperature, and pulse oximetry readings. It may also provide audiovisual information about the sleeping patient for behavioral analysis and other measurements (e.g., gastric reflux, bedwetting). The device includes electrodes, measuring instruments, samplers, filters, amplifiers, and appropriate software for processing data and providing patient diagnoses.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9999999999support@noxmedical.com

Regulatory Flags#

DUNS number
365741462
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15694311111887Nox Nasal Pressure Cannula with FilterNOX-MDR_CANAF405520112026-01-28
15694311111894Nox Nasal Pressure Cannula with FilterNOX-MDR_CANAF405520112026-01-28
15694311112112SomrystSOMRYST6510102024-12-30
15694311111672Nox SAS Body Cable - RightESNAP4SASRMPAC1US5622162025-06-06
15694311111689Nox SAS Body Cable - LeftESNAP4SASLMPAC1US5622172025-06-06
15694311111719Nox SAS Head CableESNAP10SASLMPAC1US5622182025-06-06
15694311111191Nox SAS Body Cable - RightESNAP4SASRMPAC1US5622162025-06-06
15694311111207Nox SAS Body Cable - LeftESNAP4SASLMPAC1US5622172025-06-06
15694311111214Nox SAS Head CableESNAP10SASLMPAC1US5622182025-06-06
15694311112099DeepRESPDEEPRESP2025-06-06
15694311112075Noxturnal WebNOXTURNAL_WEB2025-06-05
15694311110477Nox Mini USB CableNOX-USBCPAC15620112016-09-16
15694311110736QDC-PRO KitNOX-QDCPETL_KIT15140112016-09-16
15694311110354Nox Snap-on Lead, 100 cmNOX-ESNAP11PAC25540282016-09-16
15694311110361Nox Snap-on Double Lead, 50/100 cmNOX-ESNAP1PAC15543102016-09-16
15694311110378Nox Snap-on Double Lead, 30/50 cmNOX-PESNAP1PAC15543112016-09-16
15694311110279Nox Snap-on Lead, 50 cmNOX-ESNAP7PAC25540202016-09-16
15694311110286Nox Snap-on Lead, 30 cmNOX-PESNAP7PAC25540212016-09-16
15694311110316Nox Snap-on Lead, 150 cmNOX-ESNAP9PAC25540242016-09-16
15694311110323Nox Snap-on Lead, 100 cmNOX-PESNAP9PAC25540252016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06946725538005APKAPK Technology Co.,Ltd.DQA2026-09-04
06946725548998APKAPK Technology Co.,Ltd.DQA2026-09-04
06946725572276APKAPK Technology Co.,Ltd.DQA2026-09-04
06944413835153Telemetry MonitorEdan Instruments, Inc.DQA2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.DQA2026-08-26
00634782101633Diagnostix™AMERICAN DIAGNOSTIC CORPDQA2026-08-25
06924054300647Medical GuardianSHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-08-21
06946725572221APKAPK Technology Co.,Ltd.DQA2026-08-21
06924054300913BERRY®SHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-08-18
06924054300920BERRY®SHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-08-18
06970404880000UpnMedShenzhen Upnmed Equipment Co.,Ltd.DQA2026-08-18
06970404880017UpnMedShenzhen Upnmed Equipment Co.,Ltd.DQA2026-08-18
06970404880024UpnMedShenzhen Upnmed Equipment Co.,Ltd.DQA2026-08-18
06970404880031UpnMedShenzhen Upnmed Equipment Co.,Ltd.DQA2026-08-18
00840118620987Endure IndustriesENDURE INDUSTRIESDQA2026-08-14
06946725572078APKAPK Technology Co.,Ltd.DQA2026-08-14
06946725572085APKAPK Technology Co.,Ltd.DQA2026-08-14
06946725572092APKAPK Technology Co.,Ltd.DQA2026-08-14
04250413410637SOMNOscreen HDSOMNOmedics AGMNR2026-08-13
06924054300906BERRYSHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-07-30
04048675785910Masimo SpO2 Module for Vista 300/SShanghai Draeger Medical Instrument Co.,Ltd.DQA2026-07-13
00010939962218N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00093351041099N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00845717013550N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00845717013567N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06972040113849N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06972040113856N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06931973400563CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973400730CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973400785CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09