Model: 01.00
Catalog: ONERA STS 2 – ONERA SLEEP APP ANDROID US
DI: 08720256698357
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-15
Current Version: 2026-05-25
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
ea571d85-2387-46d0-846e-9fd5c03c0284
Distribution Status:
In Commercial Distribution
DUNS Number:
492293557
Device Count:
1
DM Exempt:
Yes
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
08720256698357
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 47567
Name: Polysomnography analyser
Definition:
A mains electricity (AC-powered) device designed to record and interpret a variety of physiologic functions during sleep to evaluate sleep/sleep-related disorders (e.g., insomnia, hypersomnia, apnoea). It typically performs electroencephalography, electrocardiography, electro-oculography, electromyography, and respiration, temperature, and pulse oximetry readings. It may also provide audiovisual information about the sleeping patient for behavioral analysis and other measurements (e.g., gastric reflux, bedwetting). The device includes electrodes, measuring instruments, samplers, filters, amplifiers, and appropriate software for processing data and providing patient diagnoses.
FDA Product Codes
MNR
Ventilatory Effort Recorder
OLV
Standard Polysomnograph With Electroencephalograph
Premarket Submissions
Submission Number:
K243220
Supplement Number:
000