SOMNOtouch RESP TOR050U

GUDID 04250413404612

SOMNOmedics GmbH

Home-use sleep apnoea recording system
Primary Device ID04250413404612
NIH Device Record Keyc0411ffc-3265-4f8e-b9d3-778f5001aa1a
Commercial Distribution StatusIn Commercial Distribution
Brand NameSOMNOtouch RESP
Version Model NumberTOR050U
Catalog NumberTOR050U
Company DUNS314112173
Company NameSOMNOmedics GmbH
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 Datefalse
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
GS104250413404612 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Number3
Public Version Date2018-07-06
Device Publish Date2016-09-18

Devices Manufactured by SOMNOmedics GmbH

04250413405640 - ABPM pro basic device2024-05-16
04250413402748 - SOMNOwatch plus ACTI2023-12-15
04250413402755 - SOMNOwatch plus ACTI2023-12-15
04250413410781 - SOMNO HD / ECO accessory2023-12-08
04250413410828 - SOMNOscreen ECO EEG 322023-12-08
04250413410835 - SOMNOtouch RESP accessory2023-12-08
04250413410842 - SOMNOtouch RESP accessory2023-12-08
04250413410859 - SOMNOtouch RESP accessory2023-12-08

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