Nox T3® System with WristOx2 511110

GUDID 15694311110569

Nox Medical ehf.

Polysomnography analyser Polysomnography analyser
Primary Device ID15694311110569
NIH Device Record Key4c3e817c-6704-4a06-8d20-0cd8c68ab366
Commercial Distribution StatusIn Commercial Distribution
Brand NameNox T3® System with WristOx2
Version Model NumberNOX-T3_USF
Catalog Number511110
Company DUNS365741462
Company NameNox Medical ehf.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kittrue
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone999-999-9999
Emailsupport@noxmedical.com
Phone999-999-9999
Emailsupport@noxmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS115694311110569 [Primary]

FDA Product Code

MNRVentilatory Effort Recorder

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-16

Devices Manufactured by Nox Medical ehf.

15694311111665 - Noxturnal US APP2021-10-26
15694311111610 - Nox A1® EEG 5 Lead Gold Electrode Cable2021-09-15
15694311111627 - Nox A1® EEG Head Cable 2021-09-15
15694311111566 - Nox A1s Recorder2021-07-19
15694311111580 - Nox A1s System2021-07-19
15694311111597 - Nox C1s Kit2021-07-19
15694311111467 - Nox T3s System2021-06-08
15694311110682 - Nox A1 Starter Sensor Kit, Adult2021-02-11

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.