ERGOMETER EBIKE III Basic

GUDID 04059358001548

ergoline GmbH

Bicycle ergometer
Primary Device ID04059358001548
NIH Device Record Key27b5eb82-53f0-4e09-9248-14bc54b1e5b9
Commercial Distribution StatusIn Commercial Distribution
Brand NameERGOMETER EBIKE III Basic
Version Model Number2017911-301
Company DUNS314403192
Company Nameergoline 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 Datetrue
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
GS104059358001548 [Primary]

FDA Product Code

ISDExerciser, Measuring

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-08-02

Devices Manufactured by ergoline GmbH

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04059358001753 - ers2 ECG Receiver2023-05-18
04059358001760 - ers2 1CH ECG Adapter2023-05-18
04059358001777 - ers2 1CH ECG Transmitter Set (Adapter)2023-05-18
04059358001821 - ergoselect 12023-05-18
04059358001838 - ers2 Basic Software2023-05-18
04059358002095 - ers2 1CH ECG Adapter US Set 5 pcs.2023-05-18

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