Primary Device ID | 04260441450574 |
NIH Device Record Key | d321576a-3362-46c1-abb1-f8c6acbc92ff |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Aluminium carrying case |
Version Model Number | 08ACC01 |
Company DUNS | 415868731 |
Company Name | CardioTek B.V. |
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 | 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 | 04260441450574 [Primary] |
DQK | Computer, Diagnostic, Programmable |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-02-07 |
Device Publish Date | 2020-01-30 |
04260441455326 - EP-TRACER | 2021-02-11 EP-TRACER 70 included in the stationary system setup. The EP-TRACER system is a computerized electrophysiology measurement syst |
04260441455425 - EP-TRACER | 2020-09-22 EP-TRACER 70 included in the portable system setup. The EP-TRACER system is a computerized electrophysiology measurement system |
04260441450482 - Adapter cables unipolar/ bipolar (set of 10) | 2020-02-25 |
04260441450574 - Aluminium carrying case | 2020-02-07 |
04260441450574 - Aluminium carrying case | 2020-02-07 |
04260441455418 - EP-TRACER | 2020-01-28 EP-TRACER 38 included in the portable system setup. The EP-TRACER system is a computerized electrophysiology measurement system |