DEVICE: MiBo Heating Pad Mask (00869086000317)
Device Identifier (DI) Information
MiBo Heating Pad Mask
3936275
In Commercial Distribution
PAIN POINT MEDICAL SYSTEMS INC.
3936275
In Commercial Distribution
PAIN POINT MEDICAL SYSTEMS INC.
Thermal heating pad with Far Infrared technology to help heating and blood circulation around the eyes.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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IRT | Pad, Heating, Powered |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
777d5f6c-9983-4708-b069-5487821ba2bf
December 18, 2023
2
April 28, 2021
December 18, 2023
2
April 28, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
2145078091
ppmglinda@outlook.com
ppmglinda@outlook.com