| Primary Device ID | 00848530084301 |
| NIH Device Record Key | ce384c26-f141-41c8-bd46-ac791740d99a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | O2 Starter Kit |
| Version Model Number | APRO025RESO2KIT |
| Catalog Number | APRO025RESO2KIT |
| 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 | 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 | |
| Phone | 877-578-6738 |
| customerservice@sunsethcs.com | |
| Phone | 877-578-6738 |
| customerservice@sunsethcs.com | |
| Phone | 877-578-6738 |
| customerservice@sunsethcs.com | |
| Phone | 877-578-6738 |
| customerservice@sunsethcs.com | |
| Phone | 877-578-6738 |
| customerservice@sunsethcs.com | |
| Phone | 877-578-6738 |
| customerservice@sunsethcs.com | |
| Phone | 877-578-6738 |
| customerservice@sunsethcs.com | |
| Phone | 877-578-6738 |
| customerservice@sunsethcs.com | |
| Phone | 877-578-6738 |
| customerservice@sunsethcs.com | |
| Phone | 877-578-6738 |
| customerservice@sunsethcs.com | |
| Phone | 877-578-6738 |
| customerservice@sunsethcs.com | |
| Phone | 877-578-6738 |
| customerservice@sunsethcs.com | |
| Phone | 877-578-6738 |
| customerservice@sunsethcs.com | |
| Phone | 877-578-6738 |
| customerservice@sunsethcs.com | |
| Phone | 877-578-6738 |
| customerservice@sunsethcs.com | |
| Phone | 877-578-6738 |
| customerservice@sunsethcs.com | |
| Phone | 877-578-6738 |
| customerservice@sunsethcs.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00848530084301 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-08-31 |
| Device Publish Date | 2018-07-31 |
| 00848530084301 | This kit contains: 1 RES032 Cylinder Wrench, 1 RES012 Tubing Connector, 1 RES018 Tubing Connecto |
| 00848530107444 | O2 Starter Kit - 1 Kit Contains: RES3025G(1), RES1107SHF(2), RES018NS(1), RES050(1), HUM008(1), |