AccessGUDID - DEVICE: Hydrotherapy Whirlpool (00645724000020)

GUDID

Device Identifier (DI) Information

Brand Name: Hydrotherapy Whirlpool
Version or Model: P-10-MH-0001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P-10-MH-0001
Company Name: Whitehall Manufacturing Co

Primary DI Number: 00645724000020
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 008312423 *Terms of Use

Device Description: MOBILE PODIATRY WHIRLPOOL W/HANDLE

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 Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
14429	Hydro-massage turbine	A mains electricity (AC-powered) device with a motor and impeller designed to be submerged in a water bathtub to aerate and circulate the water (whirlpool effect) for hydrotherapy, typically therapeutic massage for patients with musculoskeletal conditions.	Active	false
14450	Hydrotherapy bath/tank	A bathtub or tank designed to be filled with warm water and occupied by a patient for the application of various forms of physical hydrotherapy such as water jet massage or aquatic exercise, typically to help treat musculoskeletal pain and stiffness or for physical rehabilitation; it is not dedicated to flotation therapy. It may have built-in water jet nozzles or an external heating/pump system to heat and circulate the water (whirlpool effect). This device is intended to be used in a healthcare facility.	Active	false

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: Yes 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: 4545012d-4c66-4f5d-9c51-c3e8866c3a3c
Public Version Date: August 17, 2018
Public Version Number: 1
DI Record Publish Date: July 17, 2018