Inductive Effort belt - size XXXL

GUDID 04250413410521

SOMNOmedics GmbH

Polysomnograph
Primary Device ID04250413410521
NIH Device Record Keya6efe9b6-d47b-4305-953c-31c1d31d7ce5
Commercial Distribution StatusIn Commercial Distribution
Brand NameInductive Effort belt - size XXXL
Version Model NumberNGA204
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 Batchtrue
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
GS104250413410521 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-22
Device Publish Date2019-04-12

Devices Manufactured by SOMNOmedics GmbH

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
04250413400522 - SOMNOscreen Plus accessory2023-09-04

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