AccessGUDID - DEVICE: Thernal 1-Touch (B172TH10)

GUDID

Device Identifier (DI) Information

Brand Name: Thernal 1-Touch
Version or Model: Thernal 1-Touch
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: DIGITAL HEAT CORPORATION

Primary DI Number: B172TH10
Issuing Agency: HIBCC
Commercial Distribution End Date: August 08, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 080250040 *Terms of Use

Device Description: Thermal 1-Touch Ophthalmic Warmer

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):	No
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?
61023	Eye heat therapy pack, reusable	A device intended to be placed over closed eyes to apply heat/steam for the treatment of meibomian gland dysfunction (MGD), dry eye syndromes, blepharitis (inflammation of the eyelid), and other related ocular conditions. It is typically in the form of a mask-shaped fabric envelope which either: 1) contains a heat-retaining substance intended to be heated in a microwave oven prior to use; or 2) includes an envelope(s) filled with a material that produces an exothermic chemical reaction when activated. This is a reusable device.	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: 8b708d35-44c6-4320-beb5-30326c97c2bd
Public Version Date: September 20, 2021
Public Version Number: 3
DI Record Publish Date: August 08, 2019