Showering and changing table 3000

Basic Information

• Brand Name: Showering and changing table 3000
• Primary DI: 05708590357461
• Version / Model: R8435313
• Catalog Number: R8435313021
• Company Name: Pressalit A/S
• Labeler DUNS: 305656662
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-08
• Public Version: 1
• Public Version Date: 2020-06-16
• Public Version Status: New
• Public Device Record Key: add21463-a5cf-424f-af06-5940d8bdef92

Device Description

Showering and changing table 3000, fixed height, 1300 mm, with safety rail and water collection tray, lead grey

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
INT	Plinth	Physical Medicine	890.3520	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43600	Bathing/changing table, stationary	A raised device consisting of a platform with a full-body length top surface (this may be slightly concave and padded to prevent the patient easily rolling off), either mounted on a fixed frame with legs or wall-mounted (may be height-adjustable), designed to support a recumbent patient for bathing, showering or changing. It is designed to be placed in an appropriate bathing area or where the patient can be given a body bath (washed by hand by assisting staff) or shower. The device is used primarily for a patient with a disability incapable of supporting themself in an upright position. It is designed to be stationary and is used in one location.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05708590357461	GS1

Customer Contacts

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