DEVICE: Heated Eye Pad (B172HEP10)

Device Identifier (DI) Information

Heated Eye Pad
Heated Eye Pad
In Commercial Distribution

DIGITAL HEAT CORPORATION
B172HEP10
HIBCC

1
080250040 *Terms of Use
Heated Eye Pad Ophthalmic Warmer
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
Yes
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Eye heat therapy pack A non-sterile device intended to be placed over closed eyes to apply heat 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 contains a heat-retaining substance intended to be heated in a microwave oven prior to use. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
IRT Pad, Heating, Powered
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

c21c0011-e081-48a9-b611-89398ee271ed
March 29, 2018
2
July 18, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
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No CLOSE

Customer Contact

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No Customer Contact currently defined
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