DRIVEMEDICAL

Basic Information

• Brand Name: DRIVEMEDICAL
• Primary DI: 00822383582245
• Version / Model: GV974HD-BR
• 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: f5afc306-3a3c-4cf6-8aa2-24cc840ea4d9

Device Description

RollatorsBariatric Product Description: F22 Rollator, HD, Black

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: 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
ITJ	WALKER, MECHANICAL	Physical Medicine	890.3825	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37952	Bariatric walker, foldable	An all- or partially-wheeled mobility aid in the form of a waist-high, foldable, extra wide framework with handgrips and four legs designed to provide a stable support for a bariatric (obese) person when standing or ambulating; it may also be used during rehabilitation. It is a sturdy construction made of lightweight metal, plastic, and rubber materials that surrounds the front and flanks of the user. The user holds the handgrips to push the device in front of them as they move forward. The device is foldable for storage and transportation, and includes a braking mechanism; it may be width-adjustable.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00822383582245	GS1