FDA UDI In Commercial Distribution 🇺🇸 United States

Orpheus CAST App

DI: 07290017025094 · Model: 01 · ORPHEUS MEDICAL LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Orpheus CAST App
Primary DI
07290017025094
Version / Model
01
Catalog Number
MAU-EG20004
Company Name
ORPHEUS MEDICAL LTD
Labeler DUNS
533221750
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-06-05
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
96a2060e-192a-41b5-8194-cbd6736698ea

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

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
MR Unsafe
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
LLZ System, Image Processing, Radiological

GMDN Terms

Code Name
44087 Radiology information system application software

Identifiers

Type ID
Primary 07290017025094