EkoSonic® 600-30000
GUDID 00858593006493
The EkoSonic® Control Unit provides power to the Ultrasonic Core and monitors parameters during operation via the CIC. The Control Unit also provides the user interface for operator control. The EkoSonic® Control Unit is intended exclusively for use with the EkoSonic® Device.
EKOS CORPORATION
Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit Ultrasound thrombolysis system control unit| Primary Device ID | 00858593006493 |
| NIH Device Record Key | 0e31ace7-8d0b-48e4-b0d6-1534639e9914 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EkoSonic® |
| Version Model Number | 600-30000 |
| Catalog Number | 600-30000 |
| Company DUNS | 943488429 |
| Company Name | EKOS CORPORATION |
| 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 |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858593006493 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K140151
FDA Product Code
| KRA | Catheter, Continuous Flush |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-10-23 |
| Device Publish Date | 2016-12-22 |
On-Brand Devices [EkoSonic®]
| 00858593006509 | The Connector Interface Cable (CIC) is the cable assembly that connects the Infusion Catheter an |
| 00858593006493 | The EkoSonic® Control Unit provides power to the Ultrasonic Core and monitors parameters during |
| 00858593006318 | The EkoSonic® Endovascular Device consists of a single use Infusion Catheter and an Ultrasonic |
| 00858593006301 | The EkoSonic® Endovascular Device consists of a single use Infusion Catheter and an Ultrasonic |
| 00858593006295 | The EkoSonic® Endovascular Device consists of a single use Infusion Catheter and an Ultrasonic |
| 00858593006264 | The EkoSonic® Endovascular Device consists of a single use Infusion Catheter and an Ultrasonic |
| 00858593006189 | The EkoSonic® Endovascular Device consists of a single use Infusion Catheter and an Ultrasonic |
| 00858593006172 | The EkoSonic® Endovascular Device consists of a single use Infusion Catheter and an Ultrasonic |
| 00858593006165 | The EkoSonic® Endovascular Device consists of a single use Infusion Catheter and an Ultrasonic |
| 00858593006158 | The EkoSonic® Endovascular Device consists of a single use Infusion Catheter and an Ultrasonic |
| 00858593006141 | The EkoSonic® Endovascular Device consists of a single use Infusion Catheter and an Ultrasonic |
| 00858593006134 | The EkoSonic® Endovascular Device consists of a single use Infusion Catheter and an Ultrasonic |
| 00858593006028 | The EkoSonic® Endovascular Device consists of a single use Infusion Catheter and an Ultrasonic |
Trademark Results [EkoSonic]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EKOSONIC 77569254 3608703 Live/Registered |
EKOS Corporation 2008-09-12 |
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