| Primary Device ID | 00848530010638 |
| NIH Device Record Key | ba1ac6f4-188e-45bf-b286-d1764e6d4a98 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bacteria Filter |
| Version Model Number | BF516NS |
| Company DUNS | 141668116 |
| Company Name | SUNSET HEALTHCARE SOLUTIONS, INC. |
| Device Count | 1 |
| 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 | true |
| 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 | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00848530010638 [Primary] |
| CAH | Filter, Bacterial, Breathing-Circuit |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-06-28 |
| Device Publish Date | 2024-06-20 |
| 00848530099749 | 3B Stratus 5 O2 Concentrator HEPA Filter - Each |
| 00848530010355 | Bacterial/Viral-HME Filter with Luer Lock Port Foam - Each |
| 00848530096236 | Compressor Nebulizer Foam Filters |
| 00860006979560 | CPAP Final Bacteria / Viral Filter - 50/Pack |
| 00860006979553 | CPAP Final Bacteria / Viral Filter - 10/Pack |
| 00860006979546 | CPAP Final Bacteria / Viral Filter - 5/Pack |
| 00850035116517 | CPAP Final Bacteria / Viral Filter - 3/Pack |
| 00848530096229 | CPAP Final Bacteria / Viral Filter - 10/Pack |
| 00848530086466 | CPAP Final Bacteria Filters 1/Pack |
| 00848530083571 | CPAP Final Bacteria Filters 10/Pack |
| 00848530010485 | CPAP Final Bacteria Filters Bulk |
| 00848530100476 | Drive Intake Filter for 50 PSI Compressor (Comparable to OEM# 18450-FILTER) - 3/Pack |
| 00848530092610 | Extended Life Intake Bacteria Filter for CAIRE Companion 5 Oxygen Concentrator (OEM# 15062925) |
| 00848530083557 | EverFlo Intake Filter |
| 00848530010652 | Final Bacteria Filter Suction Inlet 1/4 to 3/8 Stepped Barbed Outlet 3/8 Threaded - 1/Pack |
| 10848530010642 | Final Bacteria Filter Suction Inlet 1/4 to 3/8 Threaded - 10/Pack |
| 00848530010638 | Final Bacteria Filter Inlet 5/16 Barbed Outlet 5/16 - Bulk |
| 00848530010621 | Final Bacteria Filter Inlet 5/16 Barbed Outlet 5/16 - 1/Pack |
| 00848530010614 | Final Bacteria Filter Inlet 5/16 Barbed Outlet 5/16 - 10/Pack |
| 00848530010515 | Intake Bacteria Filters - Bulk |
| 00848530010423 | Final Bacteria Filters - 1/4in to 3/8in - Bulk |
| 00848530010393 | Final Bacteria Filters — 1/4in to 1/2in Bulk |
| 10848530100688 | Respironics SimplyGo POC Inlet Filter (Comparable OEM#1095248) |
| 00848530099527 | Suction Final Bacteria Filter 1/4" - 3/8" Barbed - Bulk |
| 00848530099510 | Suction Final Bacteria Filter 1/4" - 3/8" Barbed - 1/Pack |
| 00848530104863 | Philips Respironics EverFlo Style Intake Filter Replaces # 1038831 |
| 10848530099500 | Final Bacteria Filters - 1/4in to 3/8in - 10/pk |