PT Vicinity IT Workstation

Basic Information

• Brand Name: PT Vicinity IT Workstation
• Primary DI: 04048675053682
• Version / Model: MS17277
• Company Name: Drägerwerk AG & Co. KGaA
• Labeler DUNS: 315578914
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-24
• Public Version: 5
• Public Version Date: 2023-07-25
• Public Version Status: Update
• Public Device Record Key: af8f7a05-5b8d-4d24-a9c9-0e791ae9c182
• Distribution End Date: 2022-12-31

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• 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
MSX	System,Network And Communication,Physiological Monitors	Cardiovascular	870.2300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38452	Desktop computer	A non-dedicated, electrically-powered computer designed to be stationary on a desk or other work platform. It typically includes a microprocessor [central processing unit (CPU)], a monitor, and a keyboard/mouse. When used with dedicated software the computer may function as a medical device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04048675053682	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K060254	000