FDA.reportPublic FDA data

OCuSOFT Thermal 1-Touch

Primary DI
B172OTH10
Brand
OCuSOFT Thermal 1-Touch
Company
DIGITAL HEAT CORPORATION
Model
OCuSOFT Thermal 1-Touch
Device description
OCuSOFT Thermal 1-Touch Ophthalmic Warmer
Published
2019-10-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
IRTPad, Heating, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRTPad, Heating, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B172OTH10PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Eye heat therapy pack, reusableA device intended to be placed over closed eyes to apply heat/steam for the treatment of meibomian gland dysfunction (MGD), dry eye syndromes, blepharitis (inflammation of the eyelid), and other related ocular conditions. It is typically in the form of a mask-shaped fabric envelope which either: 1) contains a heat-retaining substance intended to be heated in a microwave oven prior to use; or 2) includes an envelope(s) filled with a material that produces an exothermic chemical reaction when activated. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080250040
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B172TH10Thernal 1-TouchThernal 1-Touch2019-08-08
B172PRO0Heated Eye Pad ProHeated Eye Pad Pro2019-04-15
B172HEP10Heated Eye PadHeated Eye Pad2016-07-18
B172SC10Scorpion 1-TouchScorpion 1-Touch2018-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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