- Physicians Office Resource

JETi™ Saline Drive Unit
JETi™ - WVSDUP

Device Description

A multi-purpose assembly of devices designed to power and control the mechanical mechanism of an atherectomy and/or thrombectomy catheter (not included) during an intravascular recanalization procedure. It typically consists of an electrically-powered control unit that supplies the drive motor with electricity to power the catheter and a handpiece with hand-switch that includes the drive motor (for catheter manipulation); a foot-switch may also be included. This is a reusable device.

Environmental Conditions

Handling Environment Humidity - Percent (%) Relative Humidity

95.00
10.00

Special Storage Condition, Specify

Store in a dry place between 15°C – 25°C (59°F – 77°F) with excursions permitted.

Storage Environment Temperature - Degrees Celsius

25.00
15.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: QEZ

Device Name: Aspiration Thrombectomy Catheter

Device Class: 2

Physical State: Peripheral and/or coronary catheter

Definition: To remove thrombus from the peripheral and/or coronary vasculature through aspiration.

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: Y

Gmp Exempt Flag: removed thrombus from the vasculature

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Peripheral and/or coronary vasculature

Regulation Number: 870.5150

Third Party Flag: N

Medical Specialty: CV

Device Identifiers

Device Id: 08717648351365

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

Device Id: B139WVSDUP0

Device Type: Previous

DeviceId Issuing Agency: HIBCC

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

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