AccessGUDID - DEVICE: NUGABEST (08800091150132)

GUDID

Device Identifier (DI) Information

Brand Name: NUGABEST
Version or Model: N5-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N51-DM-11-2-022-01A-2
Company Name: Nuga Medical Co.,Ltd.

Primary DI Number: 08800091150132
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:	Yes
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?
34488	Bed/chair electric massager	A mains electricity (AC-powered) device specifically designed to be used when placed in a bed or chair. It may be fixed into appropriate beds or chairs providing other functions. It will provide a massaging therapeutic effect to the person occupying the bed or chair typically to ease aches and pains in the body. It may be used in an institution, but is typically designed for home use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JFB	Table, Physical Therapy, Multi Function

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K153054	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
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between 32 and 104 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Weight: 60 Kilogram

Device Record Status

Public Device Record Key: ed67a139-5a86-4491-b465-26bf5c82b64b
Public Version Date: October 06, 2022
Public Version Number: 1
DI Record Publish Date: September 28, 2022