FDA.reportPublic FDA data

Venture Heat

Primary DI
00876594000043
Brand
Venture Heat
Company
MATSUM INC
Model
KB171290 XXL/XXXL
Device description
Infrared Heated Back Wrap (XXL/XXXL)
Published
2020-06-02
Public version status
Update
Distribution status
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
00876594000043PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00876594000043008765940000438765940000430876594000043

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
170636802
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810021940946Venture HeatKB172436-GRY2020-06-02
00850001971058Venture HeatKB172436-BLK2020-06-02
00850001971065Venture HeatKB1724722020-06-02
00876594000098Venture HeatKB1712302020-06-02
00876594009602Venture HeatKB1712012020-06-02
00876594009619Venture HeatKB171240 L/XL2020-06-02
00876594009626Venture HeatKB171240 S/M2020-06-02
00876594009633Venture HeatKB171250 S/M2020-06-02
00876594009640Venture HeatKB171250 L/XL2020-06-02
00876594009657Venture HeatKB171280 S/M2020-06-02
00876594009664Venture HeatKB171280 L/XL2020-06-02
00876594009671Venture HeatKB171290 S/M2020-06-02
00876594009688Venture HeatKB171290 L/XL2020-06-02
00876594009695Venture HeatKB171260 S/M2020-06-02
00876594009701Venture HeatKB171260 L/XL2020-06-02
00876594009718Venture HeatKB1712102020-06-02
00810021943176Venture HeatKB1724182021-09-03

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