AccessGUDID - DEVICE: Aroma Season (06974736970002)

GUDID

Device Identifier (DI) Information

Brand Name: Aroma Season
Version or Model: M1200
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Shanghai GK Industrial Co.,Ltd.

Primary DI Number: 06974736970002
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2038
Device Count: 1
Labeler D-U-N-S® Number*: 547295180 *Terms of Use

Device Description: This is a device intended to placed over closed eyes to apply heat for the treatment of meibomian gland dysfunction, dry eye syndromes, blepharitis and other related ocular conditions

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":	Yes
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?
62194	Electric pad localized-body heating system	An assembly of mains electricity (AC-powered) devices designed for the transcutaneous application of heat to a localized body site (e.g., joint, limb) to relieve musculoskeletal pain. It consists of an electric heating pad typically made of synthetic fabric materials, and a hand-held control unit used to regulate and monitor the heat. It is intended for use in the home or a clinical setting.	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: 0749c535-a13f-425c-a6bc-56405cdee5be
Public Version Date: October 18, 2024
Public Version Number: 1
DI Record Publish Date: October 10, 2024