JETi™

Basic Information

• Brand Name: JETi™
• Primary DI: 08717648351402
• Version / Model: WV8803A
• Catalog Number: WV8803A
• Company Name: ABBOTT VASCULAR INC.
• Labeler DUNS: 964569052
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-12-08
• Public Version: 5
• Public Version Date: 2023-03-28
• Public Version Status: Update
• Public Device Record Key: fe5d21cd-5fd0-445f-b471-20d62ad88a3a

Device Description

JETi™ 8F Catheter Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QEZ	Aspiration Thrombectomy Catheter	Cardiovascular	870.5150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36142	Aspiration tray, single-use	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08717648351402	GS1
Previous	B139WV8803A1	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Catheter Length	100	Centimeter
Catheter Gauge	8	French

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a dry and dark place between 15°C – 25°C (59°F – 77°F) with excursions permitted.
• Type: Handling Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -30 – 60 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius