RENPHO heating pad

Basic Information

• Brand Name: RENPHO heating pad
• Primary DI: 16971912180016
• Version / Model: NA-H1821B
• Company Name: NINGBO BELLA VIE CO., LTD
• Labeler DUNS: 561007300
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-31
• Public Version: 1
• Public Version Date: 2021-04-08
• Public Version Status: New
• Public Device Record Key: 43e3e238-324f-4202-b867-d87dea20be85

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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IRT	Pad, Heating, Powered	Physical Medicine	890.5740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64765	Hot/cold therapy system	An electrically-powered assembly of devices intended to apply controlled heat and cold therapy (including contrast therapy) to the surface of the body for a variety of physiotherapy applications such as treatment of musculoskeletal pain, inflammation reduction, and analgesia during intramuscular injection. It includes both a control unit and a handpiece with a heating/cooling endpiece; liquid coolant is used to provide the cooling effect.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	26971912180013	GS1	Box	12	In Commercial Distribution
Primary	16971912180016	GS1