ROSCOE

Basic Information

• Brand Name: ROSCOE
• Primary DI: 00092237604175
• Version / Model: WCF-163
• Company Name: COMPASS HEALTH BRANDS CORP.
• Labeler DUNS: 827221698
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-12-11
• Public Version: 3
• Public Version Date: 2023-08-07
• Public Version Status: Update
• Public Device Record Key: ef80fcf4-d19c-486d-bf37-374df5e6df40

Device Description

WHEELCHAIR CUSHION FOAM - 16x16x3

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
35192	Soft-rubber chair cushion	A pad made of soft rubber 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
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
Package	80092237604171	GS1	CARDBOARD CARTON	12	In Commercial Distribution
Primary	00092237604175	GS1

Customer Contacts

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