| Primary Device ID | 00848530086480 | 
| NIH Device Record Key | 3b9a9b81-cf12-4ed4-9f98-f1082266adaa | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Plastic Intake Nebulizer Filters | 
| Version Model Number | BF026S | 
| Catalog Number | BF026S | 
| Company DUNS | 141668116 | 
| Company Name | SUNSET HEALTHCARE SOLUTIONS, INC. | 
| Device Count | 10 | 
| DM Exempt | false | 
| Pre-market Exempt | true | 
| MRI Safety Status | Labeling does not contain MRI Safety Information | 
| Human Cell/Tissue Product | false | 
| Device Kit | false | 
| Device Combination Product | false | 
| Single Use | false | 
| Lot Batch | true | 
| Serial Number | false | 
| Manufacturing Date | false | 
| Expiration Date | false | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | false | 
| OTC Over-The-Counter | false | 
| Phone | 877-578-6738 | 
| customerservice@sunsethcs.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00848530086480 [Primary] | 
| GS1 | 10848530086487 [Unit of Use] | 
| JRL | Unit, Filter, Membrane | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 2 | 
| Public Version Date | 2018-08-17 | 
| Device Publish Date | 2018-06-29 | 
| 00848530107444 - O2 Starter Kit | 2025-10-07 O2 Starter Kit - 1 Kit Contains: RES3025G(1), RES1107SHF(2), RES018NS(1), RES050(1), HUM008(1), RES037)1), RES2100(1), RES2102( | 
| 10848530107458 - Stratus Power Switch | 2025-10-02 Replacement Part for Stratus Power Switch - 25ea | 
| 10848530107465 - Stratus Pneumatic Valve | 2025-10-02 Replacement part for the Stratus Pneumatic Valve | 
| 10848530107335 - Invacare PerfectO2 Cabinet Access Door | 2025-09-25 Replacement part for the Invacare PerfectO2 Cabinet Access Door - OEM# 1161831 | 
| 10848530107342 - Invacare Platinum Filter Access Door | 2025-09-25 Replacement part for Invacare Platinum Filter Access Door OEM# 110667 | 
| 10848530107359 - Invacare F-Tube, PVC for PerectO2 and PerfectO2V | 2025-09-25 Replacement Part Invacare F-Tube, PVC for PerectO2 and PerfectO2V OEM# 1143446 | 
| 10848530107366 - Invacare Panel Control for PerfectO2 and PerfectO2V | 2025-09-25 Replacement Part Invacare Panel Control for PerfectO2 and PerfectO2V OEM# 1143469 | 
| 10848530107373 - Drive Power Cord | 2025-09-25 Replacement part for Drive Power Cord |