| Primary Device ID | 00848530082048 |
| NIH Device Record Key | f6e60632-b690-44b2-abef-7dc1a53f0867 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 3B Luna Style Ultrafine Filters |
| Version Model Number | CF8005 |
| Catalog Number | CF8005 |
| Company DUNS | 141668116 |
| Company Name | SUNSET HEALTHCARE SOLUTIONS, INC. |
| Device Count | 12 |
| 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 |
| 00848530104993 - RESUSCITATION KIT | 2025-08-28 Sunset Resuscitator, Adult, w/ Pop-Off, No Mask - 12pcs |
| 00848530105006 - RESUSCITATION ACCESSORY | 2025-08-28 Sunset Disposable PEEP Valve, 5-20cm H20, 15mm ID |
| 00848530105013 - RESUSCITATION ACCESSORY | 2025-08-28 Sunset Disposable Pressure Manometer, L-Shape - 25PCS |
| 00848530105037 - RESUSCITATION KIT | 2025-08-28 Sunset Adult Resuscitation Kit, M/L Masks, PEEP and Bacterial Filter
This kit contains:
1 RES8100H, 1SBC01M, 1SBC01L, RES8205B |
| 00848530105044 - RESUSCITATION KIT | 2025-08-28 Sunset Pediatric Resuscitation Kit, T/S Masks, Manometer, PEEP and Bacterial Filter
This kit contains:
1 RES8110H, 1 SBC01S, 1S |
| 10848530107243 - Oxygen Connector/Adapter | 2025-08-27 Sunset Step-Down Tubing Adaptor 5-9mmOD; 22mmID |
| 10848530107281 - Heat Moisture Exchanger | 2025-08-27 Sunset Adult In-line Large Volume HME with Gas Sampling Port |
| 00848530106966 - Tracheostomy and Suction Accessory | 2025-08-22 18fr Chimney, Straight Packed Catheter |