R-40 1378

GUDID 05060275450400

LIFELINES LIMITED

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Primary Device ID05060275450400
NIH Device Record Keye2c940dd-0245-42e7-bdc8-2b279ed54ea4
Commercial Distribution StatusIn Commercial Distribution
Brand NameR-40
Version Model NumberEEG Amplifier + WI-FI
Catalog Number1378
Company DUNS237089235
Company NameLIFELINES LIMITED
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105060275450400 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWLAmplifier, Physiological Signal

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 Date2016-09-16

On-Brand Devices [R-40]

05060275450455EEG Amplifier + BT + WI-FI Kit
05060275450448EEG Amplifier + WI-FI Kit
05060275450431EEG Amplifier + BT Kit
05060275450424EEG Amplifier Kit
05060275450417EEG Amplifier + BT + WI-FI
05060275450400EEG Amplifier + WI-FI
05060275450394EEG Amplifier + BT
05060275450387EEG Amplifier

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