| Primary Device ID | 10848530060760 |
| NIH Device Record Key | 620d5cc7-7d08-452d-bb06-8e7cb7c3f48a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Drainage Bag w/T Adapter & Hanger |
| Version Model Number | RES070 |
| Catalog Number | RES070 |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 877-578-6738 |
| customerservice@sunsethcs.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00848530060763 [Primary] |
| GS1 | 10848530060760 [Package] Contains: 00848530060763 Package: [50 Units] In Commercial Distribution |
| BYH | Drain, Tee (Water Trap) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-22 |
| Device Publish Date | 2018-09-21 |
| 00789091681564 - Oxygen Tube | 2025-05-21 25ft Oxygen Supply Tube - 5/pack |
| 00789091681595 - CPAP Tube | 2025-05-21 6ft CPAP Tubing - 3/pack |
| 00789091681601 - CPAP Tube | 2025-05-21 6ft Slim CPAP Tubing - 3/pack |
| 00789091681618 - CPAP Filter | 2025-05-21 Hypoallergenic CPAP Filter Compatible with ResMed AirSense 11 |
| 00789091681625 - CPAP Filter | 2025-05-21 Hypoallergenic CPAP Filter Compatible with ResMed S9 and AirSense 10 |
| 00848530104436 - 6IN HEPA Capsule with Removable Sticker | 2025-05-21 6IN HEPA Capsule with Removable Sticker Compatible with Invacare Mobilaire 3 and 5TM, Platinum 5 and 10 TM, and PerfectO2TM |
| 00848530104528 - Oxygen Kit | 2025-05-21 Atrium Health At Home O2 Kit This kit contains: (2) RES001, (1) RES012 , (2) RES018, (6) RES1107S, (2) RES3040G, and (1) RES003 |
| 00848530104849 - CPAP Filter | 2025-05-21 Philips Respironics DreamStation Style Disposable Ultrafine Filters Replaces #1122519 |