Parabath

Basic Information

• Brand Name: Parabath
• Primary DI: 00087453240504
• Version / Model: 24050
• Catalog Number: 24050
• Company Name: HYGENIC CORPORATION, THE
• Labeler DUNS: 004163390
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-01
• Public Version: 3
• Public Version Date: 2018-09-19
• Public Version Status: Update
• Public Device Record Key: 73c33dac-c137-4eea-a319-fc8eabda39cf

Device Description

Paraffin Heat Therapy Unit

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• 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
IMC	Bath, Paraffin	Physical Medicine	890.5110	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35232	Physical therapy paraffin wax bath	A mains electricity (AC-powered) tub/enclosure, with an internal heating assembly, intended to be filled with liquid paraffin wax for physical therapy. Symptomatic parts of the body (e.g., hands, fingers) are placed in the heated paraffin to relieve pain and stiffness caused by arthritis or other joint inflammation, muscle spasms, or to help stimulate circulation. Temperature settings and timing controls are typically included as part of the device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30087453240505	GS1		2	In Commercial Distribution
Primary	00087453240504	GS1