JETi™ 8F Catheter Kit
JETi™ - WV8803A
Device Description
A container of various instruments, dressings, pharmaceuticals, and other items necessary to perform an aspiration and related procedures. It typically includes separate sections designated to hold the various utensils required for needle biopsy, aspiration, and/or drainage. Its bottom typically has a plastic foam insert that is scored to allow placement of sharp objects and needles. This is a single-use device.
Environmental Conditions
- 95.00
- 10.00
- 60.00
- -30.00
- Store in a dry and dark place between 15°C – 25°C (59°F – 77°F) with excursions permitted.
- 25.00
- 15.00
Device Sizes
- Catheter Length: 100 Centimeter
- Catheter Gauge: 8 French
Device Sterilization
Device Sterile: True
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 IdentifiersDevice Id: 08717648351402
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: B139WV8803A1
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