SmartLinx Vitals Plus

Basic Information

• Brand Name: SmartLinx Vitals Plus
• Primary DI: 03615040000100
• Version / Model: SL-VP-BPAP-HW
• Company Name: Philips North America LLC
• Labeler DUNS: 001291111
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-04-27
• Public Version: 4
• Public Version Date: 2023-08-14
• Public Version Status: Update
• Public Device Record Key: 1e4f1364-a734-46e4-8e7b-3d11beff9e47

Device Description

VitalsPlus NiBP Suntech with RollStand

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: 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
MWI	Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)	Cardiovascular	870.2300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36862	Patient monitoring system module, interfacing	A small unit dedicated to making communication possible between the patient monitoring system and other independent devices (e.g., ventilator, infusion pump, gas analyser, display monitors) connected to the same patient, creating an interface. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device) by providing connection between disparate devices. It may also be known as a medical information bus protocol.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Previous	03615040000063	GS1
Primary	03615040000100	GS1

Premarket Submissions

Submission Number	Supplement Number
K151071	000