| Primary Device ID | 00848530080075 |
| NIH Device Record Key | 4a270f2a-998f-4a9d-81c8-8a827657dc21 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Adjustable Neoprene Chinstrap Extra Large |
| Version Model Number | CS003XL |
| Catalog Number | CS003XL |
| 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 | 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 | 00848530080075 [Primary] |
| GS1 | 10848530080072 [Package] Package: [100 Units] In Commercial Distribution |
| BTK | Strap, Head, Gas Mask |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-08-29 |
| Device Publish Date | 2018-07-29 |
| 00848530100162 - Disposable Wire-Guided Scapel for Central Venous Cannulation | 2025-12-17 Disposable Surgical Scalpel with Guide Channel and Retractable Safety Sheath: Sterile - 50/Pack |
| 00848530100179 - GuideBlade Sample Kit | 2025-12-17 GuideBlade Sample Kit - 3/pack |
| 10848530105362 - Sunset Coban Tape Roll | 2025-12-17 Use for sensor life extension or sensor cord stability 1" x 177" |
| 00848530107925 - Tracheostomy and Suction | 2025-12-17 Straight Connector 22ID; 15OD - Disposable - 25/PK |
| 00848530107642 - CPAP Filter | 2025-12-02 Private Labeled 3B Luna G3 and React G3X CPAP Reusable Filter - 2/Pack (pack of 20) |
| 00848530107659 - Repair Part | 2025-12-02 Lip Seal for Helios - Metal |
| 00848530107666 - Repair Parts | 2025-12-02 Lip Seal for Helios - Rubber |
| 00848530107673 - Repair Parts | 2025-12-02 41 Contents Gauge Rebuilt |