CAREX HEALTH BRANDS

Basic Information

• Brand Name: CAREX HEALTH BRANDS
• Primary DI: 00023601016171
• Version / Model: FGA61700 0000
• Company Name: COMPASS HEALTH BRANDS CORP.
• Labeler DUNS: 827221698
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-05-23
• Public Version: 2
• Public Version Date: 2023-09-13
• Public Version Status: Update
• Public Device Record Key: 16babade-7904-4853-a7b7-a6e12ed516f2

Device Description

HEIGHT ADJUSTABLE ROLLATOR PINK

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: Yes
• 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
ITJ	Walker, Mechanical	Physical Medicine	890.3825	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37951	Handgrip disability-assistive walker, non-powered, foldable	A non-powered, all- or partially-wheeled mobility aid in the form of a waist-high, foldable framework with handgrips and three or four legs designed to provide a stable support for a patient with a walking disability, a geriatric, obese, or infirm patient when standing or ambulating; it may also be used during rehabilitation. It is constructed of lightweight metal, plastic, and rubber materials and in the form of a mobile support structure which the patient holds and pushes in front of them as they walk. It is foldable for storage and transportation and may include a braking mechanism; it may be width-adjustable and some types may include a seat on which the patient can rest.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30023601016172	GS1		16	In Commercial Distribution
Primary	00023601016171	GS1

Customer Contacts

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