Primary Device ID | 00860008932204 |
NIH Device Record Key | ddf3eaf7-f0e9-4794-9cf8-50c4cd02ca4f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Spire Health Remote Patient Monitoring System |
Version Model Number | 700099 |
Company DUNS | 081072216 |
Company Name | CONVEXITY SCIENTIFIC LLC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Unsafe |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00860008932204 [Primary] |
DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2025-07-23 |
Device Publish Date | 2023-01-03 |
00860008932204 - Spire Health Remote Patient Monitoring System | 2025-07-23The 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 System | 2025-07-23 The Spire Health Remote Patient Monitoring System (RPM) is designed to capture, process, and longitudinally track clinically rel |
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