| Primary Device ID | 00848530080051 |
| NIH Device Record Key | fa39017b-a501-48e3-abb5-a0185cc869bb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Adjustable Neoprene Chinstrap Regular |
| Version Model Number | CS003R |
| Catalog Number | CS003R |
| 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 | 877-578-6738 |
| customerservice@sunsethcs.com |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00848530080051 [Primary] |
| GS1 | 10848530080058 [Package] Package: [100 Units] In Commercial Distribution |
| BTK | Strap, Head, Gas Mask |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-09-10 |
| Device Publish Date | 2018-05-24 |
| 00848530108618 - CPAP Filter | 2026-03-27 Replacement Reusable Foam Filter 2/pkg ResPlus Oxygo AutoPAP Machine |
| 00848530108632 - CPAP Tubing | 2026-03-27 Premium CPAP Tube, Rubber Cuffs, Gray, 8 ft. |
| 00848530108472 - Oxygen, Bacteria & HEPA Filter | 2026-03-25 Invarecare 50PSI Foam Inlet Filter - 10/PK |
| 00848530108489 - CPAP Filter | 2026-03-25 Filter, USA, AirSense 11, Standard 12 per pack |
| 10848530108646 - Repair Parts | 2026-03-25 Heat Exchanger Assembly for Perfecto2 and Perfecto2V |
| 00848530108656 - Repair Parts | 2026-03-25 Invacare Platinum 10L Flow Meter |
| 10848530108660 - Repair Parts | 2026-03-25 Sieve Everflo Muffler Insulation |
| 10848530108677 - Repair Parts | 2026-03-25 P2 Compressor Rebuild Kit with Top End and Bottom Flapper Assembly + Cup and Sleeve |