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Spire Health Remote Patient Monitoring System

FDA UDI

Class II (US FDA UDI)

by Convexity Scientific, LLC

Identity

Trade Name
Spire Health Remote Patient Monitoring System FDA UDI
Generic Name
Wearable multiple vital physiological parameter monitoring system FDA UDI
Device Name
The Spire Health Remote Patient Monitoring System (RPM) is designed to capture, process, and longitudinally track clinically relevant patient health data. FDA UDI
Model / Reference
700099 FDA UDI
Description
The Spire Health Remote Patient Monitoring System (RPM) is designed to capture, process, and longitudinally track clinically relevant patient health data. FDA UDI

Identifiers

Primary DI / UDI-DI
00860008932204 FDA UDI
510(k) Number
K192952 FDA UDI
FDA Product Code
DRG FDA UDI
MSX FDA UDI
BZQ FDA UDI
LEL FDA UDI
GMDN Term
Wearable multiple vital physiological parameter monitoring system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2910 FDA UDI
870.2300 FDA UDI
868.2375 FDA UDI
882.5050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Wearable multiple vital physiological parameter monitoring system

Spire Health Remote Patient Monitoring System by Convexity Scientific, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Wearable multiple vital physiological parameter monitoring system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Convexity Scientific, LLC

Sources (1)

  • FDA UDI ddf3eaf7-f0e9-4794-9cf8-50c4cd02ca4f 34 fields · synced Jun 8, 2026