Plastic Intake Nebulizer Filters BF026S

GUDID 00848530086480

Plastic Intake Nebulizer Filters for Respironics Innospire Elegance, Essence & Deluxe (10/pack)

SUNSET HEALTHCARE SOLUTIONS, INC.

Anaesthesia conduction filter
Primary Device ID00848530086480
NIH Device Record Key3b9a9b81-cf12-4ed4-9f98-f1082266adaa
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlastic Intake Nebulizer Filters
Version Model NumberBF026S
Catalog NumberBF026S
Company DUNS141668116
Company NameSUNSET HEALTHCARE SOLUTIONS, INC.
Device Count10
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
GS100848530086480 [Primary]
GS110848530086487 [Unit of Use]

FDA Product Code

JRLUnit, Filter, Membrane

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-08-17
Device Publish Date2018-06-29

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.