AccessGUDID - DEVICE: Ray 1 (00627987231151)

GUDID

Device Identifier (DI) Information

Brand Name: Ray 1
Version or Model: SV403
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Swift Medical Inc

Primary DI Number: 00627987231151
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 202686960 *Terms of Use

Device Description: Ray 1 is a portable hyperspectral imaging tool that allows qualified healthcare professionals, to assess wounds, at the point of care: i) to capture and digitally record images of fluorescence emitted from a wound when exposed to excitation light and ii) to capture and digitally record images through measuring surface temperature distribution.

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?
40803	Infrared thermography system	A system using infrared photography or other infrared detection techniques to produce images or graphical representations of the distribution of body surface temperature for the purpose of diagnosing and assessing various conditions and disease states. Also referred to as a thermography scanner. This system typically consists of a camera display unit that includes a scanning-condensing optical system, infrared detector, an operator's console, photographic cameras, black-body phantom, electronic or computerized controls, software and an image display and analysis units.	Active	false
63176	Fluorescence wound imaging unit	A hand-held, electrically-powered device designed to use violet light illumination and imaging to visualize fluorescent bacteria within/around a wound to assist with wound care protocols and documentation. It includes a violet light(s) for wound illumination and fluorescence, lens, display screen, and includes video/image capture technology.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QCR	Wound Autofluorescence Imaging Device

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: a73c0797-87d6-4092-b04e-4d1786f7f6ca
Public Version Date: April 26, 2022
Public Version Number: 1
DI Record Publish Date: April 18, 2022