| 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 |
| 00789091681557 - Adulat Soft Cannula | 2025-05-02 Adulat Soft Cannula with 7ft. Tubing - 5/pack |
| 00789091681571 - Adulat Soft Cannula | 2025-05-02 Adulat Soft Cannula with 4ft Tubing - 5/pack |
| 00848530104535 - CPAP Accessory | 2025-05-02 V-Com Inspiratory comfort for PAP Therapy |
| 00848530104672 - Breathing Circuit | 2025-04-29 Adult Passive Circuit with Bacteria Filter Comparable to Breas 007936 This Kit contains: (1) TUB06 and (1) BF2200 |
| 00848530089122 - Ventilator Kit | 2025-04-23 Adult Passive Heated Circuit, with Exhalation Port for Use with Philips Respironics Trilogy Comparable to OEM# 1076046, 1073227 |
| 00848530089375 - Suction Kit | 2025-04-23 Suction Kit This suction Kit contains: (1) RES023S, (1) RES024M, (1) RES025, and (1) TRAA001S |
| 00848530096861 - Oxygen Connector | 2025-04-23 Xmas Tree Connector - Non-Swivel - 10/pack |
| 00848530098728 - Mobility Support | 2025-04-23 BM001 StrongArm Comfort Cane This pack contains: (1) BM001, (1) BM001-TI, (1) BM001-BL |