S/W SUB VF9.0 Gateway

Basic Information

• Brand Name: S/W SUB VF9.0 Gateway
• Primary DI: 04049098099264
• Version / Model: MS40046
• Company Name: DRAEGER MEDICAL SYSTEMS, INC.
• Labeler DUNS: 788289952
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-02-19
• Public Version: 1
• Public Version Date: 2025-02-27
• Public Version Status: New
• Public Device Record Key: 253ccaf7-c0c7-418d-bd6c-451940e29d42

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• 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
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	870.2300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44101	Bedside information system application software	An application software program, routines, and/or algorithms intended to be used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the provision and utilization of administrative and clinical information at the patient's bedside. It is typically supplied for installation into a dedicated information system used at the patient's bedside or existing mainframe or decentralized computers/networks.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04049098099264	GS1

Premarket Submissions

Submission Number	Supplement Number
K203579	000