FDA.reportPublic FDA data

Jermei

Primary DI
06972433811246
Brand
Jermei
Company
Shenzhen Jermei Medical Device Technology Co.,Ltd
Model
JM691
Published
2026-06-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
ISAMassager, Therapeutic, Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISAMassager, Therapeutic, ElectricPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972433811246PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972433811246069724338112466972433811246

GMDN Terms#

Term, Definition table
TermDefinition
Eyelid heat therapy system control unitAn electrically-powered ophthalmic device intended to control the application of localized heat therapy to the outer eyelid surfaces of an adult patient during treatment of meibomian gland dysfunction (MGD), dry eye syndromes, blepharitis (inflammation of the eyelid), and other related ocular conditions. It is a portable unit intended to control the temperature applied to the eyelids via a skin surface applicator; the applicators are not included. It is intended to be used by a professional in a professional (e.g., clinical) setting.

Regulatory Flags#

DUNS number
554534502
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06972433811055JermeiJM8172026-01-01
06972433811062JermeiJM8182026-01-01
06972433811086JermeiJM8222026-01-01
06972433811123JermeiJM8302026-01-01
06972433811130JermeiJM8322026-01-01
06972433811185JermeiJM8382026-01-01
06972433811192JermeiJM8392026-01-01
06972433811109JermeiJM8282025-11-25
06972433811079JermeiJM8212025-10-20

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