FDA.reportPublic FDA data

MiBo Heating Pad Mask

Primary DI
00869086000317
Brand
MiBo Heating Pad Mask
Company
PAIN POINT MEDICAL SYSTEMS INC.
Model
3936275
Device description
Thermal heating pad with Far Infrared technology to help heating and blood circulation around the eyes.
Published
2021-04-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IRTPad, Heating, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRTPad, Heating, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00869086000317PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00869086000317008690860003178690860003170869086000317

GMDN Terms#

Term, Definition table
TermDefinition
Electric pad whole-body heating system padAn electrically-heated underlay or overlay intended to provide heat under or over a patient as part of an electrical heating pad system used to heat a patient’s whole body (i.e., elevate 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
2145078091ppmglinda@outlook.com

Regulatory Flags#

DUNS number
084045250
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

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