| Primary Device ID | 00848530089122 |
| NIH Device Record Key | c8eca00c-9bce-416f-944e-1eb7bedfb453 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ventilator Kit |
| Version Model Number | VC1003 |
| 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 | 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 | 00848530089122 [Primary] |
| CAH | Filter, Bacterial, Breathing-Circuit |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-04-23 |
| Device Publish Date | 2025-04-15 |
| 00848530105310 | Pediatric Passive Circuit with Swivel Exhalation Port Comparable to OEM# 1073228, 1073236 This k |
| 00848530089122 | Adult Passive Heated Circuit, with Exhalation Port for Use with Philips Respironics Trilogy Com |