Savaria

Basic Information

• Brand Name: Savaria
• Primary DI: 10688503630008
• Version / Model: Omega
• Company Name: Savaria Concord Lifts Inc
• Labeler DUNS: 245449095
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-08
• Public Version: 5
• Public Version Date: 2021-11-23
• Public Version Status: Update
• Public Device Record Key: fcd3a24b-caa7-4f05-ae2a-819e6c715c18

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
12330	Mobile patient lifting system, electrically-powered	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10688503630008	GS1

Premarket Submissions

Submission Number	Supplement Number
K960276	000