SOMNOtouch RESP accessory

GUDID 04250413404179

SOMNOmedics GmbH

Polygraph Polygraph Polygraph Polygraph Polygraph Polygraph Polygraph Polygraph Polygraph Polygraph Polygraph Polygraph Polygraph
Primary Device ID04250413404179
NIH Device Record Keyfb6b561e-5325-4ec6-a211-0f1e01148418
Commercial Distribution StatusIn Commercial Distribution
Brand NameSOMNOtouch RESP accessory
Version Model NumberTOS802
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 Usetrue
Lot Batchfalse
Serial Numberfalse
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
GS104250413404179 [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 Date2016-09-19

On-Brand Devices [SOMNOtouch RESP accessory]

04250413405022TOS010
04250413404544TOS012
04250413404469TOS095
04250413404339TOS062
04250413404322TOS060
04250413404223TOS808
04250413404216TOS807
04250413404209TOS806
04250413404193TOS805
04250413404186TOS803
04250413404179TOS802
04250413404162TOS801
04250413404155TOS800
04250413404094TOS020
04250413404087TOS011
04250413410859TOS011S
04250413410842TOS175S
04250413410835TOS110S

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