SPLY EBIKE CUFF ADULT SMALL

GUDID 04059358001531

ergoline GmbH

Bicycle ergometer Bicycle ergometer Bicycle ergometer Bicycle ergometer Bicycle ergometer Bicycle ergometer Bicycle ergometer Bicycle ergometer Bicycle ergometer Bicycle ergometer Bicycle ergometer Bicycle ergometer Bicycle ergometer Bicycle ergometer Bicycle ergometer Bicycle ergometer Bicycle ergometer Bicycle ergometer
Primary Device ID04059358001531
NIH Device Record Key93e5d8b1-0379-4a2b-849f-c46a9a8d8382
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPLY EBIKE CUFF ADULT SMALL
Version Model Number2017911-014
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 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
GS104059358001531 [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 Date2016-12-08

Devices Manufactured by ergoline GmbH

04059358002224 - optibike basic2023-05-22
04059358001746 - ers2 1CH Telemetry Transmitter2023-05-18
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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