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Augustine Temperature Management, LLC

Matched from indexed company URL: Augustine Temperature Management

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30058572643005857264Augustine Temperature Management, LLC1N2026-01-0115305 Minnetonka Blvd Minnetonka MN US 55345

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00850011479810Hillrom powered by Augustine Surgical HD - Hillrom (Baxter) Head Warming Wrap800-445-3720technical.support@hillrom.com
00855913001817"HotDog Underbody Warming Mattress + Return Electrode, 82 cm (32"")" - 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.+1 952 465 3500cs@augsurg.com
00855913001824"HotDog Underbody Warming Mattress + Return Electrode, 127 cm (50"")" - 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.+1 952 465 3500cs@augsurg.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
656541850333821K232627HotDog Warming Mattress + Return ElectrodeDWJ2024-04-18
656541585898766K230866HotDog Warming Mattress + Return ElectrodeDWJ2023-06-29
656541560766563K201779HotDog Temperature Management ControllerDWJ2020-09-11
656541712280053K112488HOTDOG PATIENT WARMING SYSTEMDWJ2011-11-23
656541493873886K094056HOTDOG MULTI FUNCTION CONTROLLERDWJ2010-06-03
656541094893059K092807HOT DOG PATIENT WARMING MATTRESS SYSTEM, MODELS WCUB, M101, M102 AND M103DWJ2009-12-10
656541817890682K052392HOT DOG PATIENT WARMING SYSTEMDWJ2006-05-04
656541837881538

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DWJ72024-04-18

PMN#

GUDID#

"HotDog Underbody Warming Mattress + Return Electrode, 127 cm (50"")" - 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.

AUGUSTINE TEMPERATURE MANAGEMENT LLC

2023-07-17

"HotDog Underbody Warming Mattress + Return Electrode, 82 cm (32"")" - 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.

AUGUSTINE TEMPERATURE MANAGEMENT LLC

2023-07-17

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

AUGUSTINE TEMPERATURE MANAGEMENT LLC

2024-09-12

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