AccessGUDID - DEVICE: Shani Darden LED Light Therapy Mask (05060534510517)

GUDID

Device Identifier (DI) Information

Brand Name: Shani Darden LED Light Therapy Mask
Version or Model: TN2118
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 115-HGSD
Company Name: I-SMART DEVELOPMENTS LIMITED

Primary DI Number: 05060534510517
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 223616320 *Terms of Use

Device Description: Shani Darden Branded Facemask Blue, Red & NIR facemask

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):	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?
62202	Blue/red/infrared phototherapy lamp	A portable, electrically-powered device designed to emit blue light, red light, and infrared radiation (heating effect) for phototherapy treatment of mild skin disorders (e.g., mild acne), superficial skin wounds, musculoskeletal symptoms (e.g., pain, spasm, stiffness), and/or for cosmetic skin rejuvenation. It may have various designs (e.g., hand-held, book-like, flexible pad for adapting to body areas) and is intended for use in the home or a clinical setting.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OLP	Over-The-Counter Powered Light Based Laser For Acne
OHS	Light Based Over The Counter Wrinkle Reduction

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K214103	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 Temperature: between -25 and 5 Degrees Celsius
Storage Environment Humidity: between 20 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a3f7bf6c-dca1-4de8-904b-d8dbccff28e0
Public Version Date: April 08, 2022
Public Version Number: 1
DI Record Publish Date: March 31, 2022