AccessGUDID - DEVICE: Hydrotherapy Whirlpool (00645724001584)

GUDID

Device Identifier (DI) Information

Brand Name: Hydrotherapy Whirlpool
Version or Model: H-75-M
Commercial Distribution Status: In Commercial Distribution
Catalog Number: H-75-M
Company Name: Whitehall Manufacturing Co

Primary DI Number: 00645724001584
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 008312423 *Terms of Use

Device Description: 75 Gallon Hi-Boy Whirlpool - Mobile

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):	Yes
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: 9cff260f-8f96-4cd7-8824-0fd359995de3
Public Version Date: August 13, 2018
Public Version Number: 1
DI Record Publish Date: July 13, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: (800) 782-7709
Email: info@whitehallmfg.com

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