| Primary Device ID | 00848530051266 |
| NIH Device Record Key | 78c63c9a-05ee-4207-9aa3-fc60fde0eeca |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Invacare Platinum 5 and 10 Style Foam Cabinet Filters |
| Version Model Number | OF9002-20 |
| Catalog Number | OF9002-20 |
| Company DUNS | 141668116 |
| Company Name | SUNSET HEALTHCARE SOLUTIONS, INC. |
| Device Count | 20 |
| 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00848530051266 [Primary] |
| GS1 | 10848530051263 [Unit of Use] |
| JRL | Unit, Filter, Membrane |
| 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 |
| 00848530107444 - O2 Starter Kit | 2025-10-07 O2 Starter Kit - 1 Kit Contains: RES3025G(1), RES1107SHF(2), RES018NS(1), RES050(1), HUM008(1), RES037)1), RES2100(1), RES2102( |
| 10848530107458 - Stratus Power Switch | 2025-10-02 Replacement Part for Stratus Power Switch - 25ea |
| 10848530107465 - Stratus Pneumatic Valve | 2025-10-02 Replacement part for the Stratus Pneumatic Valve |
| 10848530107335 - Invacare PerfectO2 Cabinet Access Door | 2025-09-25 Replacement part for the Invacare PerfectO2 Cabinet Access Door - OEM# 1161831 |
| 10848530107342 - Invacare Platinum Filter Access Door | 2025-09-25 Replacement part for Invacare Platinum Filter Access Door OEM# 110667 |
| 10848530107359 - Invacare F-Tube, PVC for PerectO2 and PerfectO2V | 2025-09-25 Replacement Part Invacare F-Tube, PVC for PerectO2 and PerfectO2V OEM# 1143446 |
| 10848530107366 - Invacare Panel Control for PerfectO2 and PerfectO2V | 2025-09-25 Replacement Part Invacare Panel Control for PerfectO2 and PerfectO2V OEM# 1143469 |
| 10848530107373 - Drive Power Cord | 2025-09-25 Replacement part for Drive Power Cord |