"HotDog Underbody Warming Mattress + Return Electrode, 89 cm (35"")"

Primary DI
00855913001848
Brand
"HotDog Underbody Warming Mattress + Return Electrode, 89 cm (35"")"
Company
AUGUSTINE TEMPERATURE MANAGEMENT LLC
Model
U530
Catalog number
U530
Device description
The HotDog Warming Mattress + Return Electrode (“Mattress”) is part of a thermal regulating system, indicated for controlling patient temperature in adult patients.Mattresses utilize a flexible semi-conductive polymer fabric which warms the patient effectively within safe limits (controlled temperature, low watt density, low thermal mass) from a controller and sensor feedback loop. They are RF sealed in durable urethane shells designed to eliminate uncleanable crevices. Via a blue cable, they are powered with a low voltage floating isolated DC current, designed to safely operate in the most demanding clinical settings.Mattresses are available with cables which enable the mattress to function as a capacitive return electrode for electrosurgery for one or two ESUs.
Published
2024-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DWJSystem, Thermal Regulating
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWJSystem, Thermal RegulatingCardiovascular2
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230866000
K232627000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230866000HotDog Warming Mattress + Return ElectrodeAugustine Temperature Management, LLC2023-06-29DWJ
K232627000HotDog Warming Mattress + Return ElectrodeAugustine Temperature Management, LLC2024-04-18DWJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855913001848PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855913001848008559130018488559130018480855913001848

GMDN Terms#

Term, Definition table
TermDefinition
Electric pad whole-body heating systemAn assembly of mains electricity (AC-powered) devices designed to heat a patient's whole body, to compensate for the loss of normal body heat, with heat generated from an externally applied pad typically containing electrical heating elements or cables. The system includes the pad designed to heat under or over the patient, and a control unit to regulate and monitor the heat. The pads are available in a variety of lengths, widths, and thicknesses to accommodate body size and applications (e.g., adult/paediatric, full-/partial-body). The system is typically used in the operating room (OR), the intensive care unit (ICU), or in neonatal and recovery units.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
965879187
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850011479810Hillrom powered by Augustine Surgical HD208915320891532026-04-23
00855913001817"HotDog Underbody Warming Mattress + Return Electrode, 82 cm (32"")"U501U5012023-07-17
00855913001824"HotDog Underbody Warming Mattress + Return Electrode, 127 cm (50"")"U502U5022023-07-17
00855913001978Waffle Grip Trendelenburg Positioning System a Hot Dog Patient Warming AccessoryA300A3002016-09-28
00855913001992HotDog Universal Warming BlanketB500B5002022-10-10
00850011479018HotDog Temperature Management SystemWC71WC712022-05-17
00850011479025HotDog Temperature Management SystemWC77WC772022-05-17
00850011479582Hillrom powered by Augustine Surgical HD208351620835162022-05-17
00850011479599Hillrom powered by Augustine Surgical HD208351820835182022-05-17
00850011479605Hillrom powered by Augustine Surgical HD208351920835192022-05-17
00850011479612Hillrom powered by Augustine Surgical HD208352020835202022-05-17
00850011479629Hillrom powered by Augustine Surgical HD208352120835212022-05-17
00855913001015Hot Dog Patient Warming System ControllerWC02WC022016-09-28
00855913001091Hot Dog Lower Body Warming Blanket, PediatricB203B2032016-09-28
00855913001107Hot Dog Patient Warming System Controller WC01WC01WC012016-09-28
00855913001251Hot Dog Lower Body Warming BlanketB103B1032016-09-28
00855913001268Hot Dog Full Body Warming BlanketB104B1042016-09-28
00855913001381Hot Dog Multi-Position Warming BlanketB105B1052016-09-28
00855913001398Hot Dog Head Warming BlanketB107B1072016-09-28
00855913001480Hot Dog Chest and Torso Warming BlanketB110B1102016-09-28

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