Device
A cloud-based software that collects, displays, analyzes, and transmits patient respiratory and physiological data from Bluetooth connected medical devices (spirometry, oximetry, B...
Manufacturer
Monitored Therapeutics, Inc.
Monitored Therapeutics, Inc.
Model: GO-03
Catalog: GO-03
DI: 00199874112060
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-04-28
Current Version: 2026-05-06
Description
A cloud-based software that collects, displays, analyzes, and transmits patient respiratory and physiological data from Bluetooth connected medical devices (spirometry, oximetry, BP, weight, etc.). Provides dashboards, and communication tools for clinicians to support patient management and communicate with patients.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
0f057536-f828-4df0-b15f-92c5198e5331
Distribution Status:
In Commercial Distribution
DUNS Number:
079316129
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00199874112060
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 57967
Name: Medical equipment clinical data interfacing software
Definition:
An application software designed for transportation, calculation, aggregation and derivation of data between patient connected medical devices and external information systems used in clinical settings for automating data collection and clinical information management. It is intended to transfer waveform, infusion data, laboratory data from medical devices/lab equipment into an electronic medical record (EMR) or an application for viewing and verification by a clinician. The data can be aggregated for, e.g., patient treatment summary calculations, ordering of infusion solutions/drugs, and laboratory sample tests; it is not primarily intended to manage diagnostic/patient images.
FDA Product Codes
OUG
Medical Device Data System