AccessGUDID - DEVICE: Omnipad Light Therapy, Dual 5x7 Pads (00858703006061)

GUDID

Device Identifier (DI) Information

Brand Name: Omnipad Light Therapy, Dual 5x7 Pads
Version or Model: 76896
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ACCELERATED CARE PLUS CORP

Primary DI Number: 00858703006061
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 828331616 *Terms of Use

Device Description: Infrared lamp for therapeutic healing

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):	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?
35147	Musculoskeletal infrared phototherapy unit, non-wearable	An electrically-powered device intended for use in the home or clinical setting to provide a source of infrared (IR) heat for localized treatment of musculoskeletal pain/injury (e.g., muscle pain, sports injury, rheumatism) and to improve blood circulation in the treated areas to facilitate healing. It may be available in a variety of forms however it is not intended to be worn on the body.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ILY	Lamp, Infrared, Therapeutic Heating

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K060191	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c8b9e4f9-0ae1-4fe3-ad67-c3a65870bbb3
Public Version Date: April 18, 2025
Public Version Number: 6
DI Record Publish Date: August 16, 2016