AccessGUDID - DEVICE: Scalara SL1/CL2 (B24010)

GUDID

Device Identifier (DI) Information

Brand Name: Scalara SL1/CL2
Version or Model: 10
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Garaventa (Canada) Ltd.

Primary DI Number: B24010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 252287586 *Terms of Use

Device Description: An electrically-powered, mobile assembly of devices designed to enable one person to lift and move an incapacitated patient or a person with a disability safely and with minimal physical effort. Also known as a patient hoist, it typically consists of a support base on wheels with a motorized lifting mechanism, mast, boom/lifting arm(s), swivel bar, a patient holding device (e.g., a sling, holder or a frame). It is typically used to lift and move the occupant in a sitting or semi-sitting position over short distances within the treatment facility, e.g., from a bed to a bathroom.

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?
30038	Stairlift, chair	A mains electricity (AC-powered) lifting device with an attached seating unit to accommodate a person with a disability, a geriatric or an infirm person to be transported up and down a staircase in a sitting position. This electromechanical device is typically attached to one or more rails which follow the shape and angle of the staircase, but may be affixed in another manner. It will typically be installed for home-use and in public venues and institutions.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PCD	Powered Stairway Chair Lift

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 7a5ca258-4ba8-4fb3-8928-ae963fc00515
Public Version Date: April 12, 2024
Public Version Number: 2
DI Record Publish Date: June 27, 2023