Spire Health Remote Patient Monitoring System

GUDID 00860008932204

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

CONVEXITY SCIENTIFIC LLC

Wearable multiple vital physiological parameter monitoring system
Primary Device ID00860008932204
NIH Device Record Keyddf3eaf7-f0e9-4794-9cf8-50c4cd02ca4f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpire Health Remote Patient Monitoring System
Version Model Number700099
Company DUNS081072216
Company NameCONVEXITY SCIENTIFIC LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860008932204 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DRGTransmitters And Receivers, Physiological Signal, Radiofrequency

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2025-07-23
Device Publish Date2023-01-03

Devices Manufactured by CONVEXITY SCIENTIFIC LLC

00860008932204 - Spire Health Remote Patient Monitoring System2025-07-23The Spire Health Remote Patient Monitoring System (RPM) is designed to capture, process, and longitudinally track clinically relevant patient health data.
00860008932204 - Spire Health Remote Patient Monitoring System2025-07-23 The Spire Health Remote Patient Monitoring System (RPM) is designed to capture, process, and longitudinally track clinically rel
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