DEVICE: MiBo Heating Pad Mask (00869086000317)

Device Identifier (DI) Information

MiBo Heating Pad Mask
3936275
In Commercial Distribution

PAIN POINT MEDICAL SYSTEMS INC.
00869086000317
GS1
February 21, 2026
1
084045250 *Terms of Use
Thermal heating pad with Far Infrared technology to help heating and blood circulation around the eyes.
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Device Characteristics

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

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
11989 External electric-heating core temperature regulation system pad
An electrically-heated underlay or overlay intended to provide heat under or over a patient as part of an external electric-heating core temperature regulation system intended to elevate a patient’s core body temperature, typically in surgical and intensive care settings. The underlay/overlay typically contains electrical heating elements or cables supplied with energy by a dedicated control unit. The underlay/overlay is available in a variety of lengths, widths, and thicknesses to accommodate body size and application (e.g., adult/paediatric, full-/partial-body). This is a reusable device.
Active false
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FDA Product Code

[?]
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
Yes CLOSE

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

777d5f6c-9983-4708-b069-5487821ba2bf
December 18, 2023
2
April 28, 2021
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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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Yes
Yes
No
Yes
No CLOSE

Customer Contact

[?]
2145078091
ppmglinda@outlook.com
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