DRIVEMEDICAL

Basic Information

• Brand Name: DRIVEMEDICAL
• Primary DI: 00822383284200
• Version / Model: COBALTBL16FS
• Company Name: Drive Devilbiss Healthcare
• Labeler DUNS: 867673159
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-01
• Public Version: 4
• Public Version Date: 2019-07-16
• Public Version Status: Update
• Public Device Record Key: 0d37a03e-3480-4639-b609-8c8af6e9fa95

Device Description

PowerRear Wheel Product Description: Cobalt K0821 RWD 18" Folding Seat, Blue

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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
INI	VEHICLE, MOTORIZED 3-WHEELED	Physical Medicine	890.3800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41637	Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, collapsible	A wheeled personal mobility device that incorporates a seat-support system for a person with a disability or a person without the full capacity to walk (not bariatric) designed to be propelled by power from one or more electric motor(s). The electronic control of speed and direction are performed by the occupant of the device. The device may be disassembled or folded for transport.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00822383284200	GS1

Premarket Submissions

Submission Number	Supplement Number
K070817	000