MEDLINE INDUSTRIES, INC.

Basic Information

• Brand Name: MEDLINE INDUSTRIES, INC.
• Primary DI: 00080196303208
• Version / Model: MDS808650
• Catalog Number: MDS808650
• Company Name: MEDLINE INDUSTRIES, INC.
• Labeler DUNS: 025460908
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-03-24
• Public Version: 3
• Public Version Date: 2023-12-18
• Public Version Status: Update
• Public Device Record Key: a6d735b1-f59e-40c8-89d2-ab9006012148

Device Description

WHEELCHAIR,RECLINER,EXCEL,22IN,DLA,ELR

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: No
• 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
IOR	Wheelchair, mechanical	Physical Medicine	890.3850	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41512	Push-rim manual wheelchair, non-bariatric	A non-powered wheeled personal mobility device with a seat designed to enable a non-bariatric person with a disability, or without the full capacity to walk, to self-mobilize by pushing specially designed rims on the wheels while seated. It is designed with a pair of larger wheels with push-rims attached whereby the occupant propels the device by rotating both wheels; it typically includes rear-fitted handles designed for optional pushing by an attendant. It provides no function outside of wheeled mobilization.	No	Active
38758	Wheelchair, power-assisted, occupant-controlled, 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 manually propelled and steered by the rotation of both rear wheels by the occupant, and when needed, power from an electric motor replaces manual wheel rotation. The device may be disassembled or folded for transport. Typically, the user is a paraplegic or quadriparetic person who desires to manually propel himself as much as possible for the exercise. The power assist feature is enabled to climb inclines, for extended distance travel, or when the user fatigues.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00080196303208	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K013761	000
K990463	000