Freedom Bath

Basic Information

• Brand Name: Freedom Bath
• Primary DI: 05055982706261
• Version / Model: AF24120US11
• Company Name: Arjohuntleigh AB
• Labeler DUNS: 355804758
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-28
• Public Version: 3
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: e0915842-69bd-469f-9e45-58164341706b

Device Description

Bath System - Freedom Bath, LA, Air-Spa

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: 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
ILJ	Bath, hydro-massage	Physical Medicine	890.5100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41576	Walk-in bathtub	A bathing (washing) receptacle designed to accommodate a patient's full body and entered by the patient through normal walking (i.e., without need to lift or swing the legs high). It may be constructed so that one side is lowered, swung open, or removed to facilitate entry; the patient easily steps or sits into the bath before the side is closed/replaced. The device is intended to enable a geriatric, infirm, or disabled patient easy access for bathing. It may have added features such as a water mixing battery with temperature control.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05055982706261	GS1