Zwim

Basic Information

• Brand Name: Zwim
• Primary DI: 00628758009009
• Version / Model: Zwim
• Catalog Number: EP900
• Company Name: Raz Design Inc
• Labeler DUNS: 206941366
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-11-06
• Public Version: 2
• Public Version Date: 2025-07-10
• Public Version Status: Update
• Public Device Record Key: 2dbab5e0-5b40-4dc1-9a21-ab26f9a55f26

Device Description

Individually configured, mobile and stationary commode chairs for use during showering and toileting. Zwim is a Self-Propel Mobile Shower / Pool (Commode) Chair with an aluminum frame.

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: 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
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 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., in the bedroom); it may additionally be used to assist with sitting on the toilet or washing in a shower or bath, however it is not a dedicated toilet seat or shower seat. Also known as a sanichair, it may incorporate hydraulically-assisted seat height and/or tilt adjustment, and/or wheels (castors).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00628758009009	GS1

Customer Contacts

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