Coolcell

Basic Information

• Brand Name: Coolcell
• Primary DI: 00643293025604
• Version / Model: RC004 - 1616
• Company Name: TRULIFE LIMITED
• Labeler DUNS: 985048669
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-09
• Public Version: 1
• Public Version Date: 2023-01-17
• Public Version Status: New
• Public Device Record Key: 4269f3e3-9675-40c7-9b4e-94ed528cb815

Device Description

Trulife Wheelchair Cushion, Relax Coolcell Black Cover RC004-1616

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• 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
11100	Wheelchair seat cushion	A padded device designed to provide support, comfort, and assistance to the occupant of a wheelchair typically by improving posture, providing back and/or side support, compensating for seat height, relieving stress points, and providing pressure alleviation for the buttocks, lumbar region, and the legs, and/or by providing an antislip mechanism. The device is typically situated behind the lower lumbar region of the back or under the buttocks and/or legs while the occupant is seated. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00643293025604	GS1