AccessGUDID - DEVICE: MiBo Heating Pad Mask (00869086000317)

GUDID

Device Identifier (DI) Information

Brand Name: MiBo Heating Pad Mask
Version or Model: 3936275
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PAIN POINT MEDICAL SYSTEMS INC.

Primary DI Number: 00869086000317
Issuing Agency: GS1
Commercial Distribution End Date: February 21, 2026
Device Count: 1
Labeler D-U-N-S® Number*: 084045250 *Terms of Use

Device Description: Thermal heating pad with Far Infrared technology to help heating and blood circulation around the eyes.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

FDA Product Code

[?]

Product Code	Product Code Name
IRT	Pad, Heating, Powered

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 777d5f6c-9983-4708-b069-5487821ba2bf
Public Version Date: December 18, 2023
Public Version Number: 2
DI Record Publish Date: April 28, 2021