AccessGUDID - DEVICE: Freedom Bath (05055982702744)

GUDID

Device Identifier (DI) Information

Brand Name: Freedom Bath
Version or Model: AF11000US11
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Arjohuntleigh AB

Primary DI Number: 05055982702744
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 355804758 *Terms of Use

Device Description: Bath System - Freedom Bath, Std, Still bath

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Walk-in bath	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.

GMDN Preferred Term Name

GMDN Definition

Walk-in bath

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.

FDA Product Code

[?]

Product Code	Product Code Name
ILJ	Bath, hydro-massage

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d46272d0-1303-4bab-92e7-ffdbc05d1888
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 26, 2016