VS System

Basic Information

• Brand Name: VS System
• Primary DI: 05060550650075
• Version / Model: SP-146-A-1
• Company Name: SUREPULSE MEDICAL LIMITED
• Labeler DUNS: 218453362
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-26
• Public Version: 1
• Public Version Date: 2025-07-04
• Public Version Status: New
• Public Device Record Key: 02104b33-a5e2-4018-9f20-d41710fca117

Device Description

VS System includes two VS Modules, a VS Display, 5 V AC/DC PSU and Operating Manual.

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: Yes
• 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
DQA	Oximeter	Cardiovascular	870.2700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35569	Neonatal multi-parameter bedside monitor	A device/device assembly designed to continuously measure and display multiple vital physiological parameters of newborn and premature infants, especially those under critical care. It is typically capable of monitoring parameters such as electrocardiogram (ECG), respiration rate, heart rate, blood pressure, and body temperature; it may also assess haemoglobin oxygen saturation (SpO2) through transcutaneous sensors that measure both transcutaneous oxygen (tcPO2) and transcutaneous carbon dioxide (tcPCO2) saturation. The system typically includes sensors with appropriate size and design for infant use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060550650075	GS1

Premarket Submissions

Submission Number	Supplement Number
K201887	000