Model: 1
Catalog: 10295
DI: 04712688051453
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-21
Current Version: 2026-05-29
Description
Twin-port CPAP mask, (w/o headgear)
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
254dd19f-9156-4199-8d40-310abed366da
Distribution Status:
In Commercial Distribution
DUNS Number:
657310868
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:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Device ID:
04712688051453
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 57813
Name: CPAP/BPAP face mask, single-use
Definition:
A non-sterile, flexible, form-shaped device designed to be placed over a user's nose and mouth to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic/silicone materials that create an airtight seal around the nose and mouth. It is available in various designs and sizes and stabilized with a headstrap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.
FDA Product Codes
BZD
Ventilator, Non-Continuous (Respirator)