Model: 2.0
DI: 00850071330137
Status: New
MRI: MR Safe
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-07
Current Version: 2026-05-15
Description
prolaio Heart Rhythm and Respiration Module
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
fba92639-a8a4-4b6c-b641-ca6d55383f59
Distribution Status:
In Commercial Distribution
DUNS Number:
118827870
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00850071330137
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 36365
Name: Electrocardiography monitoring system receiver
Definition:
An electrically-powered component of an electrocardiograpy telemetric monitoring system designed to wirelessly receive, consolidate, and display electrocardiographic (ECG) signals [sometimes with an additional parameter such as haemoglobin oxygen saturation (SpO2)] from a transmitter connected to a patient, typically ambulatory, for viewing at a receiving location (e.g., central station, bedside monitor).
FDA Product Codes
DPS
Electrocardiograph
Premarket Submissions
Submission Number:
K183322
Supplement Number:
000