NA

Basic Information

• Brand Name: NA
• Primary DI: 04055207058848
• Version / Model: 5597101
• Catalog Number: 5597101
• Company Name: Richard Wolf GmbH
• Labeler DUNS: 315304071
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-05-21
• Public Version: 1
• Public Version Date: 2024-05-29
• Public Version Status: New
• Public Device Record Key: 1acac337-58c1-4a27-8838-8f36a1dae287

Device Description

CORE.PORTAL Establishes the connection between the intra-operative networks and the hospital-wide IT systems.Provides various services centrally in all operating rooms. Included are: Installation service Receiving and forwarding of patient lists by means of DICOM WORKLIST. Receiving and forwarding of images and videos by means of DICOM STORE. Intraoperative management of recorded images and videos using MEDIA ARCHIVE APP. A server, which provides the virtual environment with the ESXi operating system, is required for installation. The server hardware is not part of the Richard Wolf portfolio and must be provided by customers on their own.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• 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	Medical Specialty	Regulation #	Device Class
OUG	Medical device data system	General Hospital	880.6310	1

GMDN Terms

Code	Name	Definition	Implantable	Status
59047	Operating room audiovisual data/device management system application software	An application software program, routines, and/or algorithms intended to be used in an operating room audiovisual data/device management system to enable the system to function according to its intended purpose. The software typically supports remote control of medical and non-medical devices, data management/documentation, and data communication/transfer within and outside of the operating room (OR) [e.g., teleconferencing, teaching/ telesurgery, networking with hospital systems]; it is not intended for long-term storage of patient demographics. It is typically installed into a dedicated integrated network of computers and peripherals.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04055207058848	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]