Spire Health Remote Patient Monitoring System

Basic Information

• Brand Name: Spire Health Remote Patient Monitoring System
• Primary DI: 00860008932204
• Version / Model: 700099
• Company Name: Spire, Inc.
• Labeler DUNS: 065461750
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-03
• Public Version: 1
• Public Version Date: 2023-01-11
• Public Version Status: New
• Public Device Record Key: ddf3eaf7-f0e9-4794-9cf8-50c4cd02ca4f

Device Description

The Spire Health Remote Patient Monitoring System (RPM) is designed to capture, process, and longitudinally track clinically relevant patient health data.

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
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	870.2910	2
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	870.2300	2
BZQ	Monitor, Breathing Frequency	Anesthesiology	868.2375	2
LEL	Device, Sleep Assessment	Neurology	882.5050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65834	Wearable multiple vital physiological parameter monitoring system	A portable assembly of electrically-powered devices intended to be worn by a patient in a healthcare or homecare setting for intermittent assessment or continuous monitoring, exclusively by a healthcare professional, of several vital physiologic parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse rate, haemoglobin oxygen saturation (SpO2), haematocrit]. It includes both physiological parameter sensors, probes, and/or electrodes (e.g., ECG electrodes, blood pressure cuff, skin patch) and processing hardware with dedicated software. It may include a monitoring screen or allow for remote communication with a smart device or central database.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860008932204	GS1

Premarket Submissions

Submission Number	Supplement Number
K192952	000