Device
A health and wellness buccal mucosal oximeter.
Manufacturer
PROSOMNUS SLEEP TECHNOLOGIES
PROSOMNUS SLEEP TECHNOLOGIES
Model: HWO2
DI: 00850022853067
Status: New
MRI: MR Unsafe
Single-use: No
Rx: No
OTC: No
First Published: 2026-04-24
Current Version: 2026-05-04
Description
A health and wellness buccal mucosal oximeter.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
ff7fc24d-c882-48e5-9094-4714f9f02caf
Distribution Status:
In Commercial Distribution
DUNS Number:
075438768
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00850022853067
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 45607
Name: Pulse oximeter
Definition:
An electrically-powered photoelectric device designed for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals are produced by light-emitting diodes (LEDs) and received by a photodetector. The device displays the SpO2 values and may also measure/display pulse rate. It is typically applied to the fingertip or around the wrist, may be single-component (with built-in probe) or multi-component (includes external probe), and may in addition wirelessly transmit measurements to a receiving location (e.g., central station, bedside monitor); it is intended to be operated by laypersons and healthcare providers.
FDA Product Codes
PGJ
Oximeter, Wellness