| Primary Device ID | 00848530099107 |
| NIH Device Record Key | 3a7264e4-6d6b-4fa8-b749-a41558c16a90 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Aerosol & Nebs |
| Version Model Number | NEB200TUBE |
| 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 | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00848530099107 [Primary] |
| CAF | Nebulizer (Direct Patient Interface) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-15 |
| Device Publish Date | 2024-08-07 |
| 00848530096250 | Compressor Nebulizer Kit with Audlt Mask and Tubing |
| 00848530096243 | Disposable Moutpiece for Mesh Nebulizer |
| 00848530098216 | Sunset Pediatric Fish Nebulizer Compressor w/ Disposable Neb Kit |
| 00848530094843 | Sunset Pediatric Bear Nebulizer Compressor w/ Disposable Neb Kit |
| 00848530093853 | Sunset Pediatric Fish Nebulizer Compressor w/Disposable & Reusable Neb Kit & Pediatric Aerosol M |
| 00848530099114 | Sunset Handheld Nebulizer Compressor - Mask |
| 00848530099107 | Sunset Handheld Nebulizer Compressor - TUBE |