FDA.reportPublic FDA data

Heating pad

Primary DI
06955293916924
Brand
Heating pad
Company
DONGGUAN CITY SINOSHINE TECHNOLOGY CO.,LTD
Model
HP169
Published
2020-09-15
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
16955293916921PackageGS16In Commercial Distribution
06955293916924PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1695529391692116955293916921
06955293916924069552939169246955293916924

GMDN Terms#

Term, Definition table
TermDefinition
Electric pad whole-body heating systemAn assembly of electrically-powered devices designed to heat a patient's whole body to compensate for the loss of normal body heat. The system includes a flat pad with electrical heating elements designed to be placed under or over the patient, and a control unit to regulate the heat; some types may be capable of monitoring the temperature at the patient’s body surface. The pad is available in a variety of lengths, widths, and thicknesses to accommodate body size and applications (e.g., adult/paediatric, full-/partial-body). It is typically used in the operating room (OR), adult or neonatal intensive care unit (ICU), recovery units, or during neonatal transportation.

Regulatory Flags#

DUNS number
528194984
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06955293916917Heating padCH22020-09-15
16955293916914Heating padCH22020-09-15
16955293916921Heating padHP1692020-09-15

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