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MiBo Heating Pad Mask

FDA UDI

Class II (US FDA UDI)

by Pain Point Medical Systems Inc.

Identity

Trade Name
MiBo Heating Pad Mask FDA UDI
Generic Name
External electric-heating core temperature regulation system pad FDA UDI
Device Name
Thermal heating pad with Far Infrared technology to help heating and blood circulation around the eyes. FDA UDI
Model / Reference
3936275 FDA UDI
Description
Thermal heating pad with Far Infrared technology to help heating and blood circulation around the eyes. FDA UDI

Identifiers

Primary DI / UDI-DI
00869086000317 FDA UDI
FDA Product Code
IRT FDA UDI
GMDN Term
External electric-heating core temperature regulation system pad FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5740 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: External electric-heating core temperature regulation system pad

MiBo Heating Pad Mask by Pain Point Medical Systems Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as External electric-heating core temperature regulation system pad.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pain Point Medical Systems Inc.

Sources (1)

  • FDA UDI 777d5f6c-9983-4708-b069-5487821ba2bf 35 fields · synced May 29, 2026