Jay Fusion

Basic Information

• Brand Name: Jay Fusion
• Primary DI: 00016958056563
• Version / Model: Jay Flow Fluid/Jay Air/ Jay Fluid w/Cryo
• Catalog Number: E2622/ E2623 / E2624 / E2625
• Company Name: SUNRISE MEDICAL (US) LLC
• Labeler DUNS: 962525056
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-12
• Public Version: 1
• Public Version Date: 2023-09-20
• Public Version Status: New
• Public Device Record Key: cf9f2f6d-675a-4313-ae0a-933abef8434d

Device Description

The JAY Fusion® is an adjustable wheelchair cushion engineered to protect against pressure injuries that features the choice of JAY Flow® Fluid, JAY® Air™, or JAY Fluid with Cryo™ Technology insert options for optimal comfort and support.

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IMP	Cushion, Wheelchair	Physical Medicine	890.3920	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64320	Air-filled chair cushion, dynamic	An electrically-powered, air-inflated arrangement of cushions and supports intended to be attached to a chair (e.g., wheelchair, dining chair) to provide comfort, improve posture, and help prevent pressure sores for the occupant, who is typically a patient affected by neuromuscular dysfunction. The device is composed of different cushions (e.g., lumbar, pelvic) which are independently inflated/deflated by an attendant and/or the occupant via electronic controls; the device may feature automatic inflation/deflation with occupant movement.	No	Active
37964	Water-filled chair cushion	A water-filled pad designed to be placed on the seat of a chair to distribute an occupant's body weight over the surface of the buttocks, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized patients especially in cases of decubitus ulcers, patients with disabilities, or patients with low body fat. It may be used in a wheelchair. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00016958056563	GS1