| Primary Device ID | 00848530105044 |
| NIH Device Record Key | 66ed8492-f3b4-4918-a4ff-8236e12addd3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RESUSCITATION KIT |
| Version Model Number | RES8400 |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 8775786738 |
| customerservice@sunsethcs.com | |
| Phone | 8775786738 |
| customerservice@sunsethcs.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00848530105044 [Primary] |
| GS1 | 10848530105041 [Package] Package: [12 Units] In Commercial Distribution |
| CAE | Airway, Oropharyngeal, Anesthesiology |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-08-28 |
| Device Publish Date | 2025-08-20 |
| 00848530105044 | Sunset Pediatric Resuscitation Kit, T/S Masks, Manometer, PEEP and Bacterial Filter This kit con |
| 00848530105037 | Sunset Adult Resuscitation Kit, M/L Masks, PEEP and Bacterial Filter This kit contains: 1 RES8 |
| 00848530104993 | Sunset Resuscitator, Adult, w/ Pop-Off, No Mask - 12pcs |