Hwato Stick-on Moxa

Basic Information

• Brand Name: Hwato Stick-on Moxa
• Primary DI: 16901452000178
• Version / Model: SAT-A-012
• Company Name: Suzhou Medical Appliance Factory
• Labeler DUNS: 653739474
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2023-11-15
• Public Version: 1
• Public Version Date: 2023-11-23
• Public Version Status: New
• Public Device Record Key: c3d619bb-1667-4565-8b16-b43909e1a17c

Device Characteristics

• Single Use: Yes
• 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: No
• Has Lot/Batch Number: Yes
• 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
IMA	Pack, Heat, Moist	Physical Medicine	890.5730	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45167	Moxa	A product of the mugwort plant (Artemisia vulgaris) used in traditional Chinese medicine for moxibustion therapy, the slow combustion of moxa as a heat treatment on acupuncture/meridian points. The device is typically applied directly to the skin (with or without adhesive), or placed in a specialized container that is applied to the skin, or onto acupuncture needle handles to heat the needle. The device is supplied in various forms (e.g., in rolls, with adhesive backing, or as loose fibres/threads). This is a single-use device.	No	Active
45273	Moxibustion container	A device designed to hold moxa (a product of the mugwort plant used in traditional Chinese medicine) and that is applied to the skin during moxibustion therapy (the slow combustion of moxa as a heat treatment on acupuncture/meridian points). The device may be shaped as a box, or container of another form, in various sizes, and made of wood, metal, ceramic, or heat-resistant plastic. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	06901452000171	GS1
Primary	16901452000178	GS1