AccessGUDID - DEVICE: NUGABEST (08800091121026)

GUDID

Device Identifier (DI) Information

Brand Name: NUGABEST
Version or Model: T20P
Commercial Distribution Status: In Commercial Distribution
Catalog Number: T20P-DM-11-2-022-01A-0
Company Name: Nuga Medical Co.,Ltd.

Primary DI Number: 08800091121026
Issuing Agency: GS1
Commercial Distribution End Date: September 07, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 690034673 *Terms of Use

Device Description: Personal heating therapeutic device

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:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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

FDA Product Code

[?]

Product Code	Product Code Name
IRT	Pad, Heating, Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 878a278e-e7f5-460e-8c45-a037e1dc8c9e
Public Version Date: October 06, 2022
Public Version Number: 1
DI Record Publish Date: September 28, 2022