Heated Eye Pad Pro

GUDID B172PRO0

Ophthalmic warmer with timer

DIGITAL HEAT CORPORATION

Eye heat therapy pack
Primary Device IDB172PRO0
NIH Device Record Keyd8a29862-cbb4-4e26-9258-f092830e5c42
Commercial Distribution StatusIn Commercial Distribution
Brand NameHeated Eye Pad Pro
Version Model NumberHeated Eye Pad Pro
Company DUNS080250040
Company NameDIGITAL HEAT CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB172PRO0 [Primary]

FDA Product Code

IRTPad, Heating, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-23
Device Publish Date2019-04-15

Devices Manufactured by DIGITAL HEAT CORPORATION

B172OTH10 - OCuSOFT Thermal 1-Touch2021-09-20 OCuSOFT Thermal 1-Touch Ophthalmic Warmer
B172TH10 - Thernal 1-Touch2019-09-13 Thermal 1-Touch Ophthalmic Warmer
B172PRO0 - Heated Eye Pad Pro2019-04-23Ophthalmic warmer with timer
B172PRO0 - Heated Eye Pad Pro2019-04-23 Ophthalmic warmer with timer
B172SC10 - Scorpion 1-Touch2018-09-07 Scorpion Compress Ophthalmic Warmer
B172HEP10 - Heated Eye Pad2018-03-29 Heated Eye Pad Ophthalmic Warmer

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