AccessGUDID - DEVICE: Vertical Lifts (B24012)

GUDID

Device Identifier (DI) Information

Brand Name: Vertical Lifts
Version or Model: CPL
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Garaventa (Canada) Ltd.

Primary DI Number: B24012
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 252287586 *Terms of Use

Device Description: The Elvoron CPL is a vertical platform lift equipped with a full height cab and a non-load bearing ceiling. It looks and feels like a small elevator but costs much less. The Elvoron CPL is designed to provide access for people with disabilities in commercial buildings. Simple constant pressure operation and swing door access ensure reliability and ease of operation for passengers.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
17819	Wheelchair/occupant lift	A mains electricity (AC-powered) device designed for moving (lifting) a wheelchair and the seated occupant from one level to another to provide a means of vertical access. It typically consists of a platform, with no roof, onto which the patient wheels the wheelchair, using controls to move up or down; the lift does not move within a lift shaft. The lift is designed for use in buildings such as hospitals, homes, offices, and stores.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ING	Elevator, Wheelchair, Portable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K033469	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f234ee53-d53e-4f40-918c-78a7228237c6
Public Version Date: April 16, 2024
Public Version Number: 1
DI Record Publish Date: April 08, 2024