Primary Device ID | 04059358002224 |
NIH Device Record Key | 40fbb218-22c4-4e72-a593-5c31c3eb27d6 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | optibike basic |
Version Model Number | 196001 |
Company DUNS | 314403192 |
Company Name | ergoline GmbH |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 | true |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04059358002224 [Primary] |
ISD | Exerciser, Measuring |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-05-22 |
Device Publish Date | 2023-05-12 |
04059358002224 - optibike basic | 2023-05-22 |
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 |