Raz

Basic Information

• Brand Name: Raz
• Primary DI: 00628758003601
• Version / Model: Raz-AT600
• Company Name: Raz Design Inc
• Labeler DUNS: 206941366
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-01
• Public Version: 1
• Public Version Date: 2023-08-09
• Public Version Status: New
• Public Device Record Key: f4b2596a-36ed-40bd-83c8-e44eec180e9f

Device Description

Individually configured, mobile and stationary commode chairs for use during showering and toileting. The Raz-AT600 is a Heavy Duty Mobile Shower Commode Chair (up to 600 lb weight capacity) with stainless steel frame and components, four locking 6” (150mm) casters and commode pan. The specially engineered, Weight Assist Spring System (WASS) is available in two weight ranges and is adjustable to accommodate the user’s weight and Center of Mass (CoM) for tilt operation with minimal effort by the attendant. The AT600 has 25o tilt range to assist with pressure reduction and redistribution, postural support, comfort, and transfers.

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• 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
INN	Chair, Adjustable, Mechanical	Physical Medicine	890.3100	1

GMDN Terms

Code	Name	Definition	Implantable	Status
40539	Commode, manual	A non-active, manually-operated transportable device in the form of a chair with a built-in receptacle for collecting urine and faeces intended to enable a patient with a disability to urinate/defecate away from a bathroom or fixed toilet (e.g., during shower). Also known as a sanichair, it may include hydraulically-assisted seat height adjustment, and may or may not be supplied with wheels (castors).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00628758003601	GS1

Customer Contacts

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