Device
The OxyTrainer Advantage is a respiratory muscle trainer (RMT). It trains both inspiratory and expiratory muscles independently.
Manufacturer
D R BURTON HEALTHCARE, LLC
D R BURTON HEALTHCARE, LLC
Model: 1
Catalog: 565
DI: 00851232007745
Status: Update
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-28
Current Version: 2026-05-21
Description
The OxyTrainer Advantage is a respiratory muscle trainer (RMT). It trains both inspiratory and expiratory muscles independently.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
3
Record Key:
ed55b016-39ba-4b2a-8fc4-e74d399fedf2
Distribution Status:
In Commercial Distribution
DUNS Number:
080384219
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
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:
Yes
Identifiers
Item #1 - Pkg Type:
CASE
Item #1 - Device ID:
20851232007749
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
10
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00851232007745
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00851232007745
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 63172
Name: CPAP/BPAP unit ambient air filter, reusable
Definition:
A non-sterile filter designed to be installed in a continuous positive airway pressure (CPAP) and/or bi-level positive airway pressure (BPAP) unit to filter particulates from the ambient air prior to inhalation; it is not intended to filter medical gases. It is typically a flat sheet or pad composed of tightly woven materials or foam intended to be installed over the air inlet of the CPAP/BPAP device to remove particulates/impurities; it is not intended to filter microbes. This is a reusable device.
FDA Product Codes
ION
Exerciser, Non-Measuring