FDA.reportPublic FDA data

Heating Pad

Primary DI
06975641820116
Brand
Heating Pad
Company
Ningbo Kangheng Appliance Co., Ltd.
Model
BM-F0213A
Published
2022-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
16975641820113PackageGS18In Commercial Distribution
06975641820116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697564182011316975641820113
06975641820116069756418201166975641820116

GMDN Terms#

Term, Definition table
TermDefinition
External electric-heating core temperature regulation system padAn 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.

Regulatory Flags#

DUNS number
699453331
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975641820017Heating PadBM-F0110A2022-09-26
06975641820024Heating PadBM-F0111A2022-09-26
06975641820031Heating PadBM-F0112A2022-09-26
06975641820048Heating PadBM-F0113A2022-09-26
06975641820055Heating PadBM-ZF0111A2022-09-26
06975641820062Heating PadBM-ZF0112A2022-09-26
06975641820079Heating PadBM-ZF0114A2022-09-26
06975641820086Heating PadBM-F0210A2022-09-26
06975641820093Heating PadBM-F0211A2022-09-26
06975641820109Heating PadBM-F0212A2022-09-26
06975641820123Heating PadBM-ZF0211A2022-09-26
06975641820130Heating PadBM-ZF0212A2022-09-26
06975641820147Heating PadBM-ZF0214A2022-09-26
16975641820014Heating PadBM-F0110A2022-09-26
16975641820021Heating PadBM-F0111A2022-09-26
16975641820038Heating PadBM-F0112A2022-09-26
16975641820045Heating PadBM-F0113A2022-09-26
16975641820052Heating PadBM-ZF0111A2022-09-26
16975641820069Heating PadBM-ZF0112A2022-09-26
16975641820076Heating PadBM-ZF0114A2022-09-26

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