ERGOMETER ergoselect 4 P

GUDID 04059358001593

ergoline GmbH

Bicycle ergometer
Primary Device ID04059358001593
NIH Device Record Keyb86026f7-b34b-4143-9bc5-9abe08b1cbf4
Commercial Distribution StatusIn Commercial Distribution
Brand NameERGOMETER ergoselect 4 P
Version Model Number191001.P
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
GS104059358001593 [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 Date2017-11-20

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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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