FDA.reportPublic FDA data

Heating Pad

Primary DI
16975641820052
Brand
Heating Pad
Company
Ningbo Kangheng Appliance Co., Ltd.
Model
BM-ZF0111A
Published
2022-09-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
16975641820052PackageGS16In Commercial Distribution
06975641820055PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697564182005216975641820052
06975641820055069756418200556975641820055

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

Regulatory Flags#

DUNS number
699453331
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
06975641820116Heating PadBM-F0213A2022-09-26
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
16975641820069Heating PadBM-ZF0112A2022-09-26
16975641820076Heating PadBM-ZF0114A2022-09-26

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