| Primary Device ID | 10848530081482 |
| NIH Device Record Key | 0935e089-e00b-425e-ab3c-9f60680f4b57 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sunset Halo Style Chinstrap |
| Version Model Number | CS025 |
| Catalog Number | CS025 |
| 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 | 00848530081485 [Primary] |
| GS1 | 10848530081482 [Package] Contains: 00848530081485 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 | 2018-10-18 |
| Device Publish Date | 2018-09-17 |
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| 00848530096137 - Nebulizer Kit | 2025-05-29 Compressor Nebulizer Kit 1 kit contains T-Piece, 7ft Supply Tube, 6in Aerosol Tube, and Jet Nebulizer |
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