Primary Device ID | 04260441455425 |
NIH Device Record Key | a9537a72-5eba-4211-9ae2-1d742db1279b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | EP-TRACER |
Version Model Number | 40SYS02 |
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 |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04260441455425 [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 | 2020-09-22 |
Device Publish Date | 2020-09-14 |
04260441455418 | EP-TRACER 38 included in the portable system setup. The EP-TRACER system is a computerized elec |
04260441455425 | EP-TRACER 70 included in the portable system setup. The EP-TRACER system is a computerized elec |
04260441455326 | EP-TRACER 70 included in the stationary system setup. The EP-TRACER system is a computerized el |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() EP-TRACER 79158810 4801736 Live/Registered |
Schwarzer Cardiotek GmbH 2014-08-27 |