Guardian

Basic Information

• Brand Name: Guardian
• Primary DI: 10193489187977
• Version / Model: WCAA0096
• Catalog Number: WCAA0096
• Company Name: MEDLINE INDUSTRIES, INC.
• Labeler DUNS: 025460908
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-21
• Public Version: 1
• Public Version Date: 2023-12-29
• Public Version Status: New
• Public Device Record Key: 43ef10bf-d6e8-4ccb-b006-09084e922661

Device Description

SIDE FRAME, RIGHT, SB, K3

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: Yes
• 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
IML	ARMREST, WHEELCHAIR	Physical Medicine	890.3920	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32981	Wheelchair armrest	A small platform, typically cushioned, mounted on the lateral ends of a wheelchair to provide the user with a support on which to place the arms. The position of the platform (e.g., height) may be adjustable to suit the comfort and utility of the user.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10193489187977	GS1

Customer Contacts

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