Device
The ProSomnus Charging Station is used to charge the HWO2/RPMO2 devices.
Manufacturer
PROSOMNUS SLEEP TECHNOLOGIES
PROSOMNUS SLEEP TECHNOLOGIES
Model: Charging Station
DI: 00850022853050
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-04-24
Current Version: 2026-05-04
Description
The ProSomnus Charging Station is used to charge the HWO2/RPMO2 devices.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
b7d5bbc5-7be3-4692-aa4f-12dff7b5699d
Distribution Status:
In Commercial Distribution
DUNS Number:
075438768
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
Yes
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:
00850022853050
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 64667
Name: Noninvasive device battery charger/transceiver/cable
Definition:
An electrically-powered device designed to supply an electrical charge to the battery of a noninvasive device to recharge it for operation, and to both receive data from and transmit data to noninvasive devices via a direct/wired or wireless connection. It is typically in the form of an electronic circuitry housing with a cable.
FDA Product Codes
None