Device
Private Label Canada" Ultra Fine Filter Respironics DreamStation 2 Disposable Filter (2/Pack)
Manufacturer
SUNSET HEALTHCARE SOLUTIONS, INC.
SUNSET HEALTHCARE SOLUTIONS, INC.
Model: CF1012-2PLC
DI: 00848530108847
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-04-27
Current Version: 2026-05-05
Description
Private Label Canada" Ultra Fine Filter Respironics DreamStation 2 Disposable Filter (2/Pack)
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
c94a61a3-142f-48f1-aad8-04978fc5b0c2
Distribution Status:
In Commercial Distribution
DUNS Number:
141668116
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:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00848530108847
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 63171
Name: CPAP/BPAP unit ambient air filter, single-use
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 single-use device.
FDA Product Codes
JRL
Unit, Filter, Membrane