AccessGUDID - DEVICE: Orpheus CAST App (07290017025094)

GUDID

Device Identifier (DI) Information

Brand Name: Orpheus CAST App
Version or Model: 01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MAU-EG20004
Company Name: ORPHEUS MEDICAL LTD

Primary DI Number: 07290017025094
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 533221750 *Terms of Use

Device Description: A Windows based desktop widget application that can be connected to the laptop’s webcam, the Orpheus GATE or a USB connected camera. It is useful also to drag images from a USB connected camera/smartphone or from the PC/Laptop directory and upload to the Orpheus System. For example: discharge workflow in which clinicians record a video session with the patient explaining their care path and requirements after discharge.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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):	Yes
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?
44087	Radiology information system application software	An application software program, routines, and/or algorithms used as or in a radiology information system (RIS) to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within/between facilites, to support the administrative and clinical activities associated with the provision and utilization of radiology services and facilities. It may be used for patient scheduling and work-list generation for specific radiological systems; it may be used in conjunction with PACS and include various technology imaging modalities. It is installed into a dedicated radiology information system or existing mainframe or decentralized computers/network.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LLZ	System, Image Processing, Radiological

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: 96a2060e-192a-41b5-8194-cbd6736698ea
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: June 05, 2017