FDA.reportPublic FDA data

SEIRIN MOXSAFE

Primary DI
04547248831028
Brand
SEIRIN MOXSAFE
Company
SEIRIN CORPORATION
Model
MOXSAFE 500
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 32 stainless steel holders and 500 pieces of smokeless moxa.
Published
2018-05-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IMAPack, Heat, Moist

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMAPack, Heat, MoistPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14547248831025PackageGS11In Commercial Distribution
04547248831028PrimaryGS10
24547248831022Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1454724883102514547248831025
04547248831028045472488310284547248831028
2454724883102224547248831022

GMDN Terms#

Term, Definition table
TermDefinition
MoxaA 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.

Contacts#

Phone, Email table
PhoneEmail
800 722 8775customerservice@lhasaoms.com

Regulatory Flags#

DUNS number
693307373
Device count
500
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04547248021108SEIRIN ACUPUNCTURE NEEDLED-type (Dtype SP) No.1(0.16)x15mm2026-05-31
04547248021153SEIRIN ACUPUNCTURE NEEDLED-type (Dtype SP) No.2(0.18)x15mm2026-05-31
04547248021207SEIRIN ACUPUNCTURE NEEDLED-type (Dtype SP) No.3(0.20)x15mm2026-05-31
04547248021382SEIRIN ACUPUNCTURE NEEDLED-type (Dtype SP) No.5(0.25)x15mm2026-05-31
04547248022112SEIRIN ACUPUNCTURE NEEDLEJ-ProPak10 No.1(0.16)x30mm2026-05-31
04547248022211SEIRIN ACUPUNCTURE NEEDLEJ-ProPak10 No.3(0.20)x30mm2026-05-31
04547248024055SEIRIN ACUPUNCTURE NEEDLEJ-type (JSP type) No.02(0.12)x30mm2026-05-31
04547248024062SEIRIN ACUPUNCTURE NEEDLEJ-type (JSP type) No.02(0.12)x40mm2026-05-31
04547248024086SEIRIN ACUPUNCTURE NEEDLEJ-type (JSP type) No.01(0.14)x30mm2026-05-31
04547248024093SEIRIN ACUPUNCTURE NEEDLEJ-type (JSP type) No.01(0.14)x40mm2026-05-31
04547248024116SEIRIN ACUPUNCTURE NEEDLEJ-type(JSP type) No.1(0.16)x30mm2026-05-31
04547248024123SEIRIN ACUPUNCTURE NEEDLEJ-type (JSP type) No.1(0.16)x40mm2026-05-31
04547248024130SEIRIN ACUPUNCTURE NEEDLEJ-type (JSP type) No.1(0.16)x50mm2026-05-31
04547248024161SEIRIN ACUPUNCTURE NEEDLEJ-type (JSP type) No.2(0.18)x30mm2026-05-31
04547248024178SEIRIN ACUPUNCTURE NEEDLEJ-type (JSP type) No.2(0.18)x40mm2026-05-31
04547248024185SEIRIN ACUPUNCTURE NEEDLEJ-type (JSP type) No.2(0.18)x50mm2026-05-31
04547248024215SEIRIN ACUPUNCTURE NEEDLEJ-type (JSP type) No.3(0.20)x30mm2026-05-31
04547248024222SEIRIN ACUPUNCTURE NEEDLEJ-type (JSP type) No.3(0.20)x40mm2026-05-31
04547248024239SEIRIN ACUPUNCTURE NEEDLEJ-type (JSP type) No.3(0.20)x50mm2026-05-31
04547248024246SEIRIN ACUPUNCTURE NEEDLEJ-type(JSP type) No.3(0.20)x60mm2026-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04979844700116NEW MOXA STICKYAMASHO CO.,LTD.IMA2025-02-03
04979844930506MOGUSAN'S MOXA BOXYAMASHO CO.,LTD.IMA2025-02-03
04979844931008DEDICATED CARBONIZED MOXAYAMASHO CO.,LTD.IMA2025-02-03
04979844580015NON-SMOKE CHOSEI-KYU MOXAYAMASHO CO.,LTD.IMA2024-06-17
04979844580039NON-SMOKE CHOSEI-KYU MOXAYAMASHO CO.,LTD.IMA2024-06-17
16901452000178Hwato Stick-on MoxaSuzhou Medical Appliance FactoryIMA2023-11-15
06901452000171Hwato Stick-on MoxaSuzhou Medical Appliance FactoryIMA2023-11-15
14897076722454Tiger.Warm.STENS PLUS INDUSTRIAL COMPANYIMA2023-06-05
14897076722546Tiger.Warm.STENS PLUS INDUSTRIAL COMPANYIMA2023-06-05
06971175122368sunwin momShanghai Senwo Industry Co., Ltd.IMA2023-05-13
14897076721778Roll.Smoke.LSuzhou Shenlong Medical Apparatus Co., Ltd.IMA2023-04-07
00057475570446BIOS LivingThermor LtdIMA2023-03-31
10057475570443BIOS LivingThermor LtdIMA2023-03-31
08800018916537Smokeless Mini MoxaDong Bang Medical co.,Ltd.IMA2023-01-15
08800018916544GuGwan Moxa SmokelessDong Bang Medical co.,Ltd.IMA2023-01-15
08800018916551GuGwan MoxaDong Bang Medical co.,Ltd.IMA2023-01-15
08800018916568Gold MoxaDong Bang Medical co.,Ltd.IMA2023-01-15
18800018914561DBC Moxa BurnerDong Bang Medical co.,Ltd.IMA2023-01-15
18800018916411Tiger Warmer SmallDong Bang Medical co.,Ltd.IMA2023-01-15
18800018916428Tiger Warmer LargeDong Bang Medical co.,Ltd.IMA2023-01-15
18800018916435CHARCOAL SMOKELESS MOXA CONESDong Bang Medical co.,Ltd.IMA2023-01-15
18800018916442GuGwan Burning Bowl 1HoleDong Bang Medical co.,Ltd.IMA2023-01-15
18800018916459GuGwan Burning Bowl 5HolesDong Bang Medical co.,Ltd.IMA2023-01-15
18800018916510"""Moxa Shield """Dong Bang Medical co.,Ltd.IMA2023-01-15
18800018916534Smokeless Mini MoxaDong Bang Medical co.,Ltd.IMA2023-01-15
18800018916541GuGwan Moxa SmokelessDong Bang Medical co.,Ltd.IMA2023-01-15
18800018916558GuGwan MoxaDong Bang Medical co.,Ltd.IMA2023-01-15
18800018916565Gold MoxaDong Bang Medical co.,Ltd.IMA2023-01-15
28800018916432CHARCOAL SMOKELESS MOXA CONESDong Bang Medical co.,Ltd.IMA2023-01-15
06971175125567sunwin momShanghai Senwo Industry Co., Ltd.IMA2022-12-30