Embla

GUDID 00382830048484

RemLogic 4.0 Software (English)

Embla Systems Ltd

Sleep disorder interpretive software
Primary Device ID00382830048484
NIH Device Record Key8129e692-91a3-4b21-949a-cf87474ae803
Commercial Distribution StatusIn Commercial Distribution
Brand NameEmbla
Version Model Number025406
Company DUNS203408612
Company NameEmbla Systems Ltd
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 Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100382830048484 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLZAutomatic Event Detection Software For Polysomnograph With Electroencephalograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-12-11
Device Publish Date2018-11-20

Devices Manufactured by Embla Systems Ltd

00382830025973 - Natus2020-02-17 XactTrace Univ Sensor -Thorax
00382830027205 - Natus2020-02-17 XactTrace Univ Sensor- Abdomen
00382830026277 - Xltek2020-02-17 XactTrace Snap Sensor Cable - Thorax
00382830027076 - Xltek2020-02-17 XactTrace Lock - Thorax EBG
00382830027083 - Xltek2020-02-17 XactTrace Reusable Belt - Small Abdomen
00382830027090 - Xltek2020-02-17 XactTrace Reusable Belt - Small Thorax
00382830027106 - Xltek2020-02-17 XactTrace Reusable Belt - Medium Abdomen
00382830027113 - Xltek2020-02-17 XactTrace Reusable Belt - Medium Thorax

Trademark Results [Embla]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EMBLA
EMBLA
97486768 not registered Live/Pending
Gregory Gerard Matthew Duggan
2022-07-02
EMBLA
EMBLA
97271668 not registered Live/Pending
Volvo Car Corporation
2022-02-17
EMBLA
EMBLA
86947653 5068253 Live/Registered
Natus Medical Incorporated
2016-03-21
EMBLA
EMBLA
86038231 not registered Dead/Abandoned
Scicutis LLC
2013-08-14
EMBLA
EMBLA
79371221 not registered Live/Pending
embla ApS
2023-02-14
EMBLA
EMBLA
75354712 2210665 Dead/Cancelled
Armor Bond Building Products, Inc.
1997-09-10
EMBLA
EMBLA
74593056 2012511 Live/Registered
NATUS MEDICAL INCORPORATED
1994-10-31
EMBLA
EMBLA
74544596 2010632 Dead/Cancelled
ICL Systems AB
1994-07-01

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