AccessGUDID - DEVICE: HotDog Underbody Warming Mattress + Return Electrode, 127 cm (50") (00855913001824)

GUDID

Device Identifier (DI) Information

Brand Name: HotDog Underbody Warming Mattress + Return Electrode, 127 cm (50")
Version or Model: U502
Commercial Distribution Status: In Commercial Distribution
Catalog Number: U502
Company Name: AUGUSTINE TEMPERATURE MANAGEMENT LLC

Primary DI Number: 00855913001824
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 965879187 *Terms of Use

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 contain a green cable which enables the mattress to function as a capacitive return electrode for electrosurgery.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
37329	Electric pad whole-body heating system	An 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.	Active	false
42551	Electrosurgical return electrode, reusable	A dispersive conductor intended to be fastened to a patient and connected to an electrosurgical/radio-frequency ablation system generator, to allow return of electrical current from the patient to the generator during an electrosurgical procedure. It has a large surface area and is fastened to the patient's body typically where the greatest surface area can be covered in closest proximity to the surgical site. It may be designed with permanently attached leads. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DWJ	System, Thermal Regulating
GEI	Electrosurgical, Cutting & Coagulation & Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K230866	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a6e3188d-a52e-4060-86a5-288999765c90
Public Version Date: July 25, 2023
Public Version Number: 1
DI Record Publish Date: July 17, 2023