| Primary Device ID | 00848530040758 |
| NIH Device Record Key | 43cd45af-4ea1-4e87-bbf1-e87707f40f96 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Deluxe Full Face CPAP Mask with Removable Cushion - Small *No Headgear* |
| Version Model Number | CM005SNH |
| Catalog Number | CM005SNH |
| Company DUNS | 141668116 |
| Company Name | SUNSET HEALTHCARE SOLUTIONS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 877-578-6738 |
| customerservice@sunsethcs.com |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00848530040758 [Primary] |
| BZD | Ventilator, Non-Continuous (Respirator) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
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