JETi™ Pump Set

JETi™ Pump Set
JETi™ - WV-JSET

A collection of flexible, noninvasive, double-lumen tubing and associated items intended to provide twin conduits in a surgical irrigation/aspiration system to deliver irrigation solution (e.g., saline) from its source (e.g., gravity feed bag) to a surgical cannula (not included) through one lumen, and provide aspiration (suction) through the other lumen (i.e., enables both irrigation and aspiration), during a surgical procedure (e.g., dental, laparoscopy). The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device.

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 Id: 08717648353284

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