| Primary Device ID | 00848530088965 |
| NIH Device Record Key | f53d1c04-5f6d-4ec5-9606-2eabf068db79 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Portable Suction Machine |
| Version Model Number | SU100DC |
| Catalog Number | SU100DC |
| 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 | true |
| Lot Batch | false |
| Serial Number | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00848530088965 [Primary] |
| GS1 | 10848530088962 [Package] Package: [2 Units] In Commercial Distribution |
| JCX | Apparatus, Suction, Ward Use, Portable, Ac-Powered |
| 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 |
| 00848530003142 - Oxygen Kit | 2024-07-03 Oxygen Kit |
| 00848530003159 - Oxygen Kit | 2024-07-03 Oxygen Kit |
| 00848530003357 - Oxygen Kit | 2024-07-03 Oxygen Kit |
| 00848530003449 - Oxygen Kit | 2024-07-03 Oxygen Kit |
| 00848530050436 - Oxygen Filter | 2024-07-03 "Foam Cabinet 3 1/2"" x 6 1/8"" x 1/4"" Compatible with: Devilbiss MC Units (All Units)" |
| 00848530060343 - Oxygen Connector/Adapter | 2024-07-03 Oxygen Enrichment Adapter - Bulk |
| 00848530061968 - Oxygen Kit | 2024-07-03 Oxygen Kit |
| 00848530061999 - Oxygen Kit | 2024-07-03 Oxygen Kit |