| Primary Device ID | 00848530104436 |
| NIH Device Record Key | c79bb5bd-6517-4ece-a19a-36d2eda42ff3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 6IN HEPA Capsule with Removable Sticker |
| Version Model Number | CS204 |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 | 00848530104436 [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 | 2025-05-21 |
| Device Publish Date | 2025-05-13 |
| 00848530010690 | 6in HEPA Capsule with Removable Sticker (1/pack) |
| 00848530104436 | 6IN HEPA Capsule with Removable Sticker Compatible with Invacare Mobilaire 3 and 5TM, Platinum |