Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005857264

FEI Number

3005857264

Entity Name

Augustine Temperature Management, LLC

City/State/Country

Minnetonka, MN, US

Establishment Address

15305 Minnetonka Blvd, Minnetonka, MN 55345, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Augustine Temperature Management, LLC (Owner Number: 9076948)

Owner / Operator Contact Address

6581 CITY WEST PARKWAY, --, Eden Prairie, MN 55344, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K112488

PMA Number

N/A

All Registered Proprietary Names

HotDog Warming Mattress + Return Electrode Hot Dog Multi Function Controller HotDog Temperature Management Controller HotDog Warming Mattress + Return Electrode HOT DOG PATIENT WARMING WaffleGrip Hot Dog Patient Warming System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2025-02-18
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-02-18
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2012-11-29
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2020-10-28
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-07-14
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2023-07-14
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2005-09-16
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2022-10-07
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2012-11-29

Official Correspondent

Garrett Augustine

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Augustine Temperature Management, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K171373	3M Company	3M Bair Hugger Model 675 Total Temperature Management System	2017-10-10
K083336	Smiths Medical Asd, Inc.	LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL SW-2013, LEVEL 1 SNUGGLE WARM LEFT LATERAL	2009-06-03
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-2010	Cincinnati Sub-Zero Products Inc	2	WarmAir 135 Thermal Regulating System. Catalog Numbers: 86186-115 V, 06186-115 V (sold in the U.S.) and #86185-100 V ( not sold in the U.S.). Intended for warming patients before, during and after surgery, and other specialty procedures.
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

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3012315097	CARE ESSENTIALS INTERNATIONAL PVT LTD.	Ahmedabad Gujarat, IN
9680284	3M EDUMEX, S.A DE C.V	CD. JUAREZ Chihuahua, MX
3012307300	ICU Medical, Inc.	Minneapolis, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005857264. Last updated year: 2026. Please use registration number 3005857264 when referencing this establishment in official correspondence.