Whitehall Thermalators

Basic Information

• Brand Name: Whitehall Thermalators
• Primary DI: 00645724004431
• Version / Model: T-12-M-0037
• Catalog Number: T12M0037
• Company Name: Whitehall Manufacturing Co
• Labeler DUNS: 008312423
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-02-12
• Public Version: 1
• Public Version Date: 2019-03-11
• Public Version Status: New
• Public Device Record Key: fc610451-ec1d-4210-9fac-2c499b612837

Device Description

THERMALATOR, T-12-M-EXE-EG02

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: Yes
• 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
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00645724004431	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]