Biovitals Analytics Engine

Basic Information

• Brand Name: Biovitals Analytics Engine
• Primary DI: 08885018690021
• Version / Model: 2.0
• Company Name: BIOFOURMIS SINGAPORE PTE. LTD.
• Labeler DUNS: 659253421
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-28
• Public Version: 3
• Public Version Date: 2023-02-03
• Public Version Status: Update
• Public Device Record Key: 7aceb156-be10-468f-b7cd-756e478a0d0d

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
PLB	Multivariate Vital Signs Index	Cardiovascular	870.2300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66625	Physiologic monitor-installed software	An application software program intended to be installed on a dedicated monitoring device (i.e., software in a medical device), to process and display real-time patient physiologic data [e.g., electrocardiogram (ECG), blood pressure, heart rate, SpO2] to facilitate data viewing, management, and communication in a clinical setting. It may in addition notify clinicians of events, patients at risk, and/or manage workflows. It is not intended for intraoperative/intraprocedural monitoring and is neither dedicated to neonatal nor obstetrical monitoring.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08885018690021	GS1

Premarket Submissions

Submission Number	Supplement Number
K183282	000