AccessGUDID - DEVICE: Minuteful for Wound at Home (17290017272877)

GUDID

Device Identifier (DI) Information

Brand Name: Minuteful for Wound at Home
Version or Model: WND PNT.EN.GEN
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HEALTHY.IO LTD

Primary DI Number: 17290017272877
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 600437232 *Terms of Use

Device Description: The Minuteful for Wound device is a comprehensive wound management system designed to assist in the management of chronic wounds. It is intended to support healthcare professionals in the clinical assessment of wounds by measuring, documenting, monitoring, and managing information relevant to the progression and treatment of chronic wounds. The device comprises Calibration Stickers, a Web Portal for healthcare professionals to review and manage wound data, and two separate smartphone applications. These applications are utilized for the collection of wound data: one for healthcare professionals and one for lay users under the guidance and supervision of healthcare professionals.

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
64263	Wound management image-analysis software	An application software program intended to facilitate monitoring and management of a wound during the healing process based primarily on digital images of the wound. When installed on a device with a camera (e.g., hyperspectral imaging camera, smartphone), the software enables image analysis, clinical data collection and sharing, and might assist in assessing wounded tissue viability to support clinical decision making. It may incorporate artificial intelligence (AI)/deep learning algorithms.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FXN	Tape, Camera, Surgical

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 10 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8a3c591f-9917-4249-b5e8-951e8fb7ea6d
Public Version Date: March 11, 2024
Public Version Number: 1
DI Record Publish Date: March 01, 2024