Model: 1.0
DI: 00860008953117
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-12
Current Version: 2026-05-20
Description
Sleep Scoring Package
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
520dc8d2-5bea-489d-a2c0-ceddc285355f
Distribution Status:
In Commercial Distribution
DUNS Number:
081010564
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
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:
00860008953117
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 64938
Name: Sleep disorder interpretive software, professional-only
Definition:
An interpretive software program intended to be used exclusively by healthcare professionals to collect and analyse patient physiological data during sleep and publish reports to assist diagnosis of sleep disorders (e.g., insomnia, sleep apnoea). It is typically used as part of a polysomnography study using a wide range of data of [e.g., electrocardiogram (ECG), electroencephalogram (EEG), haemoglobin oxygen saturation (SpO2), chest wall motion, airflow, eye movement].
FDA Product Codes
OLZ
Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Premarket Submissions
Submission Number:
K250058
Supplement Number:
000