3B Luna Style Ultrafine Filters CF8005

GUDID 00848530082048

3B Luna Style Ultrafine Filters (12/pack)

SUNSET HEALTHCARE SOLUTIONS, INC.

CPAP/BPAP unit ambient air filter, reusable
Primary Device ID00848530082048
NIH Device Record Keyf6e60632-b690-44b2-abef-7dc1a53f0867
Commercial Distribution StatusIn Commercial Distribution
Brand Name3B Luna Style Ultrafine Filters
Version Model NumberCF8005
Catalog NumberCF8005
Company DUNS141668116
Company NameSUNSET HEALTHCARE SOLUTIONS, INC.
Device Count12
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone877-578-6738
Emailcustomerservice@sunsethcs.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100848530082048 [Primary]
GS110848530082045 [Unit of Use]

FDA Product Code

JRLUnit, Filter, Membrane

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-07-05
Device Publish Date2018-06-04

Devices Manufactured by SUNSET HEALTHCARE SOLUTIONS, INC.

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00848530106478 - Peform Health PrecisionFit Full Face CPAP Mask- Large2025-07-30 CPAP Mask with cushion and headgear - Large
00848530106485 - Perform Health PrecisionFit Full Face Cushion - Small2025-07-30 CPAP Cushion - Small
00848530106492 - Perform Health PrecisionFit Full Face Cushion - Medium2025-07-30 CPAP Cushion - Medium
00848530106508 - Perform Health PrecisionFit Full Face Cushion - Large2025-07-30 CPAP Cusion - Large
10848530106710 - CPAP Carry Bag for ResMed AirSense 112025-07-29 CPAP Carry Bag
00848530106447 - Oxygen Kit2025-07-25 Oxygen Kit- This kit: RES1107(4) RES3025 (2) RES032 (1) RES035 (1) RES012 (2) RES003 (1)

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