Breeze Quiet One Kit OF11001SP

GUDID 00848530051198

This kit contains: 2 OF1005 Foam Cabinet Filters, 1 BF316 Final Bacteria Filter, 1 BFH6S 6in HEPA Capsule

SUNSET HEALTHCARE SOLUTIONS, INC.

CPAP/BPAP unit ambient air filter, single-use
Primary Device ID00848530051198
NIH Device Record Key45385061-cf37-477b-b079-f95e53959a04
Commercial Distribution StatusIn Commercial Distribution
Brand NameBreeze Quiet One Kit
Version Model NumberOF11001SP
Catalog NumberOF11001SP
Company DUNS141668116
Company NameSUNSET HEALTHCARE SOLUTIONS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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
GS100848530051198 [Primary]

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 Date2018-08-31
Device Publish Date2018-07-31

Devices Manufactured by SUNSET HEALTHCARE SOLUTIONS, INC.

00848530106454 - Perform Health PrecisionFit Full Face CPAP Mask - Small2025-07-30 CPAP mask with cushion and headgear
00848530106461 - Peform Health PrecisionFit Full Face CPAP Mask - Mediom2025-07-30 CPAP mask with cushion and headgear
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)

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.