SEIRIN MOXSAFE

Basic Information

• Brand Name: SEIRIN MOXSAFE
• Primary DI: 04547248831035
• Version / Model: MOXSAFE 100
• Company Name: SEIRIN CORPORATION
• Labeler DUNS: 693307373
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2018-05-24
• Public Version: 3
• Public Version Date: 2020-05-15
• Public Version Status: Update
• Public Device Record Key: c973b934-c739-49f1-87f4-c3fcaeead438

Device Description

Moxsafe consists of a lightweight stainless steel holder that houses a cylinder of ultra-pure carbonized mugwort. Designed to fit on Japanese and Korean style acupuncture needles, Moxsafe's holder prevents moxa ash from falling on the patient. Moxsafe is easy to use, odorless, safe and smokeless. Box includes 6 stainless steel holders and 100 pieces of smokeless moxa.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• 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
IMA	Pack, Heat, Moist	Physical Medicine	890.5730	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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
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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	14547248831032	GS1	BOX	1	In Commercial Distribution
Primary	04547248831035	GS1
Unit of Use	24547248831039	GS1

Customer Contacts

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