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Augustine Temperature Management, LLC

US

Last updated September 17, 2026

Information

Country
US
Address
15305 Minnetonka Blvd, Minnetonka, MN, 55345
LinkedIn
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Facebook
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Email
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Phone
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PRRC Contact
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EUDAMED SRN
—
FDA FEI Number
3005857264
DUNS Number
—

Catalogue (49)

DeviceModel / ReferenceRegistriesClassStatus
Hot Dog Patient Warming System Demo Equipment WC02D
FDA UDI
Class IIActive
Hot Dog Lower Body Warming Blanket B103
FDA UDI
Class IIActive
HotDog Underbody Warming Mattress + Return Electrode, 127 cm (50") U502
FDA UDI
Class IIActive
WaffleGrip Trendelenburg Positioning Kit for Warming Pad, 10 Pack A307
FDA UDI
Class IActive
Hot Dog Patient Warming System Multifunction Controller Refurbished Equipment WC51R
FDA UDI
Class IIActive
Hot Dog Patient Warming System Demo Equipment WC01D
FDA UDI
Class IIActive
Hot Dog Pediatric Head Warming Wrap, Small B270
FDA UDI
Class IIActive
Hot Dog Patient Warming System Multifunction Controller Refurbished Equipment WC52R
FDA UDI
Class IIActive
HotDog Temperature Management System WC77
FDA UDI
Class IIActive
WaffleGrip 2084054
FDA UDI
Class IActive
Hillrom powered by Augustine Surgical HD 2083520
FDA UDI
Class IIActive
HotDog Underbody Warming Mattress + Return Electrode, 82 cm (32") U501
FDA UDI
Class IIActive
Hot Dog Pediatric Underbody Warming Mattress U220
FDA UDI
Class IIActive
Hot Dog Pediatric Head Warming Wrap, Large B271
FDA UDI
Class IIActive
Hot Dog Underbody Warming Mattress, 82 cm (32in) U101
FDA UDI
Class IIActive
Hillrom powered by Augustine Surgical HD 2083519
FDA UDI
Class IIActive
HotDog Underbody Warming Mattress + Return Electrode, 89 cm (35") U530
FDA UDI
Class IIActive
Hot Dog Patient Warming System Multifunction Controller Demo Equipment WC52D
FDA UDI
Class IIActive
Hot Dog Patient Warming System Controller Refurbished Equipment WC01R
FDA UDI
Class IIActive
HotDog Universal Warming Blanket B500
FDA UDI
Class IIActive
Hot Dog Patient Warming System Controller WC02
FDA UDI
Class IIActive
Hillrom powered by Augustine Surgical HD 2083516
FDA UDI
Class IIActive
Hot Dog Underbody Warming Mattress, 127 cm (50in) U102
FDA UDI
Class IIActive
Hot Dog Trendelenburg Warming Mattress, 89 cm (35in) U300
FDA UDI
Class IIActive
WaffleGrip PadLock Bracket Set A330
FDA UDI
Class IActive
Waffle Grip Trendelenburg Positioning System a Hot Dog Patient Warming Accessory A300
FDA UDI
Class IIActive
Hot Dog Patient Warming System Controller Refurbished Equipment WC02R
FDA UDI
Class IIActive
Hot Dog Lower Body Warming Blanket without Flaps B108
FDA UDI
Class IIActive
WaffleGrip 2083515
FDA UDI
Class IActive
Hot Dog Chest and Torso Warming Blanket B110
FDA UDI
Class IIActive
Hillrom powered by Augustine Surgical HD 2083521
FDA UDI
Class IIActive
Hot Dog Patient Warming System Multifunction Controller WC52
FDA UDI
Class IIActive
WaffleGrip Trendelenburg Positioning Kit + BackSaver Slide Sheet A301
FDA UDI
Class IActive
HotDog Temperature Management System WC71
FDA UDI
Class IIActive
Hillrom powered by Augustine Surgical HD 2083518
FDA UDI
Class IIActive
Hot Dog Full Body Warming Blanket B104
FDA UDI
Class IIActive
WaffleGrip A302
FDA UDI
Class IActive
Hot Dog Head Warming Blanket B107
FDA UDI
Class IIActive
Hot Dog Patient Warming System Multifunction Controller Demo Equipment WC51D
FDA UDI
Class IIActive
Hot Dog Chest and Torso Warming Blanket with wire reinforced edge B110W
FDA UDI
Class IIActive
Hot Dog Patient Warming System Controller WC01 WC01
FDA UDI
Class IIActive
Hot Dog Lower Body Warming Blanket, Pediatric B203
FDA UDI
Class IIActive
Hot Dog Multi-Position Warming Blanket B105
FDA UDI
Class IIActive
Hot Dog Patient Warming System Multifunction Controller WC51
FDA UDI
Class IIActive
HotDog Warming Mattress + Return Electrode K232627
FDA 510(k)
Class IIActive
HotDog Warming Mattress + Return Electrode K230866
FDA 510(k)
Class IIActive
HotDog Warming Mattress + Return Electrode K210727
FDA 510(k)
Class IIActive
HotDog Temperature Management System K220941
FDA 510(k)
Class IIActive
HotDog Temperature Management Controller K201779
FDA 510(k)
Class IIActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (13)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

DateRecall No.ClassStatusReason
Dec 16, 2024Z-1197-2025—open, classified

There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connector cable on the mattress can experience the same type of deflection that caused the intermittent connection with the cables connecting to the ESU.

Dec 16, 2024Z-1198-2025—open, classified

There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connector cable on the mattress can experience the same type of deflection that caused the intermittent connection with the cables connecting to the ESU.

Dec 16, 2024Z-1199-2025—open, classified

There is over-molding that stabilizes the connection between the cable and cable-entry on the mattress. It turns out that after about a year of use, the connector cable on the mattress can experience the same type of deflection that caused the intermittent connection with the cables connecting to the ESU.

Dec 4, 2024Z-0700-2025—open, classified

Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to Power-on self-test error code "EA POST".

Dec 4, 2024Z-0701-2025—open, classified

Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to Power-on self-test error code "EA POST".

Dec 4, 2024Z-0702-2025—open, classified

Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to Power-on self-test error code "EA POST".

Feb 15, 2024Z-1172-2025—open, classified

Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact .

Feb 15, 2024Z-1171-2025—open, classified

Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Contact .

Mar 14, 2022Z-0841-2025—completed

HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".

Mar 14, 2022Z-0839-2025—completed

HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".

Mar 14, 2022Z-0842-2025—completed

HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".

Mar 14, 2022Z-0840-2025—completed

HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".

Mar 14, 2022Z-0843-2025—completed

HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".