DRIVEMEDICAL

Basic Information

• Brand Name: DRIVEMEDICAL
• Primary DI: 00822383531571
• Version / Model: 14301
• Company Name: Drive Devilbiss Healthcare
• Labeler DUNS: 867673159
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-21
• Public Version: 1
• Public Version Date: 2019-07-01
• Public Version Status: New
• Public Device Record Key: a087910d-6e8a-4c0f-8946-524442e0654e

Device Description

Pressure PreventionSeat and Back Cushions Product Description: 16x23.5 Gen.use adj back cush 22-26in

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
KIC	CUSHION, FLOTATION	Physical Medicine	890.3175	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41057	Lumbar cushion	A soft pillow or pad used to provide support and comfort to the user's lower back, often during the treatment and/or prevention of musculoskeletal disorders or injuries. The device may be used to support the natural curvature of the lower spine, improve posture, relax muscles, and relieve painful pressure points. The device is typically placed between the lower back and the back of a seat/chair while the user is seated.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50822383531576	GS1		6	In Commercial Distribution
Primary	00822383531571	GS1