DRIVEMEDICAL

Basic Information

• Brand Name: DRIVEMEDICAL
• Primary DI: 00822383248769
• Version / Model: 14880
• Company Name: Drive Devilbiss Healthcare
• Labeler DUNS: 867673159
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-19
• Public Version: 4
• Public Version Date: 2021-05-10
• Public Version Status: Update
• Public Device Record Key: 999b568c-897a-4b4c-929c-7b366ee38ca3

Device Description

Pressure PreventionSeat and Back Cushions Product Description: W/C Cushion Molded,16x16x2, 1/ea, 6/cv

Device Characteristics

• Single Use: No
• 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: 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
KIC	CUSHION, FLOTATION	Physical Medicine	890.3175	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
Package	50822383248764	GS1		6	In Commercial Distribution
Primary	00822383248769	GS1