AccessGUDID - DEVICE: Joovv Go 2.0 (00855501008280)

GUDID

Device Identifier (DI) Information

Brand Name: Joovv Go 2.0
Version or Model: PT500-F0488
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: JOOVV, INC.

Primary DI Number: 00855501008280
Issuing Agency: GS1
Commercial Distribution End Date: July 01, 2031
Device Count: 1
Labeler D-U-N-S® Number*: 104893063 *Terms of Use

Device Description: The Joovv Go 2.0 is a handheld phototherapy device that emits light in the Red and Near Infrared spectrum.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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
ILY	Lamp, Infrared, Therapeutic Heating

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
Storage Environment Temperature: between 0 and 40 Degrees Celsius
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 554c7267-da79-4ad4-9cd2-4a09d548c95d
Public Version Date: July 09, 2021
Public Version Number: 1
DI Record Publish Date: July 01, 2021