| Primary Device ID | 00848530081089 |
| NIH Device Record Key | 58269188-98ab-4777-8733-c93597adb87d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CPAP Kit |
| Version Model Number | TUB006SSCF2107PL |
| 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 | 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 | 00848530081089 [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 | 2024-06-25 |
| Device Publish Date | 2024-06-17 |
| 00860005613274 | (26) CF1009NT-1PL, (4) CF1009F-1PL |
| 00848530100858 | (1) TUB06 (1) RES3007 (1) RES019NS (1) BF220NS |
| 00848530090135 | 1 TUB06, 4 CF1010NS |
| 00848530090128 | 1 TUB06, 5 CF1010NS |
| 00848530093013 | Ascend FF Small Kit |
| 00848530093006 | Ascend FF Large Kit |
| 00848530092993 | Ascend Nasal Small Kit 2 Cushions |
| 00848530092986 | Ascend Nasal Medium Kit 2 Cushions |
| 00848530092979 | Ascend Nasal Large Kit 2 Cushions |
| 00848530092962 | Ascend Nasal Small Kit 5 Cushions |
| 00848530092955 | Ascend Nasal Medium Kit 5 Cushions |
| 00848530092948 | Ascend Nasal Large Kit 5 Cushions |
| 00848530092931 | Ascend FF Medium Kit |
| 00848530092818 | Complete Mask Kit |
| 00860004356202 | ASNU001DSLGPK |
| 00848530093242 | ASLE090CPAPKITA |
| 00848530092665 | ACPA007CPAPKITDS |
| 00848530092658 | CPAP Kit - ACPA007CPAPKITAS |
| 00848530091552 | AISI001CM006M |
| 00848530091545 | AISI001CM006S |
| 00848530091330 | ASIM007DSKIT |
| 00848530087234 | AINT014CF2107Combo |
| 00848530087227 | AINT014CF1010combo |
| 00848530082277 | APAR008TUB06CF1007C2 |
| 00848530082260 | APAR008TUB06CF1009NT |
| 00848530081089 | TUB006SSCF2107PL |
| 00850035116371 | Halo Style Chinstrap |
| 00848530001322 | PR System One Remstar COMBO PACK **6 CF1009NT 1 CF1009F** |