HIGHLANDER

Basic Information

• Brand Name: HIGHLANDER
• Primary DI: 00817650020117
• Version / Model: CPL
• Catalog Number: CPL0400SACI
• Company Name: Harmar Summit, LLC
• Labeler DUNS: 144008062
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2023-04-19
• Public Version Status: Update
• Public Device Record Key: 620ba5d9-4ac9-4939-9ee2-150b88857f85

Device Description

COMMERCIAL PLATFORM LIFT, 400 STANDARD, AC, INSIDE

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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
ING	Elevator, wheelchair, portable	Physical Medicine	890.3930	2

GMDN Terms

Code	Name	Definition	Implantable	Status
30036	Assistive passenger lift	An elevator designed to be used and operated by a person with a disability and to accommodate their assistive devices (e.g., a wheelchair) which move in a vertically shaft (up and down) to provide a method of transport between two or more vertical levels (e.g., floors in a building and ship decks).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817650020117	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K091881	000