DEVICE: HealthLight (00858935006051)

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Device Identifier (DI) Information

HealthLight
HL-FM
502005
HEALTHLIGHT LLC
00858935006051
GS1
1
Face Mask, Infrared Phototherapy Unit
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Infrared phototherapy unit A mains electricity (AC-powered) device that provides a source of infrared (IR) heat to treat areas of the body. It is typically used to help treat, e.g., muscle pains, sports injuries, rheumatism. As well as relieving pain the heat delivered to the body surface encourages blood flow to the affected area for faster healing. This device is also used in the care and treatment of newborn babies who can be or must be removed from an enclosed incubator for examination/treatment.
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FDA Product Code

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Product Code Product Code Name
ILY Lamp, Infrared, Therapeutic Heating
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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 Status

In Commercial Distribution
July 29, 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
No
Yes
No CLOSE

Customer Contact

[?]
224-231-0342
cjohl@healthlightllc.com
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