FDA.reportPublic FDA data

SoftHeat

Primary DI
20328785000195
Brand
SoftHeat
Company
KAZ, INC.
Model
HP1000V1
Device description
Electric Heat Pad, MaxHeat by SoftHeat, 4 heat settings, 10" x 22", moist even heat, 60 minute auto-off, machine wash entire pad.
Published
2016-07-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

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
20328785000195PackageGS19In Commercial Distribution
00328785000191PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2032878500019520328785000195
00328785000191003287850001913287850001910328785000191

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
1-800-477-0457consumerrelations@kaz.com

Regulatory Flags#

DUNS number
001483890
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00328785002034VicksVNT200US2020-09-29
20328785002038VicksVNT200US2020-09-29
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10328785004844HoneywellHUL535BV22020-04-03
10328785004875HoneywellHUL520LV32020-04-03
10328785004882HoneywellHUL520RV32020-04-03
10328785004868HoneywellHUL520BV32020-01-28
10328785003212VicksVUL6002019-12-30

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