AccessGUDID - DEVICE: Whitehall (B478TA12MT1RS750)

GUDID

Device Identifier (DI) Information

Brand Name: Whitehall
Version or Model: Whirlpool
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Whitehall Manufacturing Co

Primary DI Number: B478TA12MT1RS750
Issuing Agency: HIBCC
Commercial Distribution End Date: February 14, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 008312423 *Terms of Use

Device Description: Hydrotherapy

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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):	No
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

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: 604d2452-706f-4b9f-86d0-b72f73104b3b
Public Version Date: February 15, 2019
Public Version Number: 3
DI Record Publish Date: February 01, 2017