Primary Device ID | 04059358001531 |
NIH Device Record Key | 93e5d8b1-0379-4a2b-849f-c46a9a8d8382 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SPLY EBIKE CUFF ADULT SMALL |
Version Model Number | 2017911-014 |
Company DUNS | 314403192 |
Company Name | ergoline GmbH |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04059358001531 [Primary] |
ISD | Exerciser, Measuring |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2016-12-08 |
04059358002224 - optibike basic | 2023-05-22 |
04059358001746 - ers2 1CH Telemetry Transmitter | 2023-05-18 |
04059358001753 - ers2 ECG Receiver | 2023-05-18 |
04059358001760 - ers2 1CH ECG Adapter | 2023-05-18 |
04059358001777 - ers2 1CH ECG Transmitter Set (Adapter) | 2023-05-18 |
04059358001821 - ergoselect 1 | 2023-05-18 |
04059358001838 - ers2 Basic Software | 2023-05-18 |
04059358002095 - ers2 1CH ECG Adapter US Set 5 pcs. | 2023-05-18 |