| Primary Device ID | 00848530082048 |
| NIH Device Record Key | f6e60632-b690-44b2-abef-7dc1a53f0867 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 3B Luna Style Ultrafine Filters |
| Version Model Number | CF8005 |
| Catalog Number | CF8005 |
| Company DUNS | 141668116 |
| Company Name | SUNSET HEALTHCARE SOLUTIONS, INC. |
| Device Count | 12 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | 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 | 00848530082048 [Primary] |
| GS1 | 10848530082045 [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 | 2018-07-05 |
| Device Publish Date | 2018-06-04 |
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| 10848530101814 - Celon Wet Bands 30.5 x 40mm | 2024-03-28 Celon Wet Bands 30.5x40mm |
| 10848530101821 - Celon Wet Bands 66 x 120mm | 2024-03-28 Celon Wets Bands 66x120mm |
| 10848530103504 - Löwenstein LUISA Ventilator and prisma Style Reusable CPAP Filter | 2024-03-28 Movair Luisa Ventilator Resuable Filter (OEM#WM29928) - 2/Pack |
| 10848530103511 - One Piece Tracheostomy Tie Adult 2.5cm x 43cm (17in) | 2024-03-28 Adult One Piece Trach Ties, 2.5x43cm (17in) - 20/box |
| 10848530103528 - One Piece Tracheostomy Tie Pediatric 2.5cm x 30cm (11.5in) | 2024-03-28 Pediatric One Piece Trach Ties, 2.5x30cm (11.5in) - 20/box |
| 10848530103535 - Two Piece Tracheostomy Tie Adult 2.5cm x 51cm (20in) | 2024-03-28 Adult Two Piece Trach Ties, 2.5x51cm (20in) - 20/box |
| 10848530103542 - Two Piece Tracheostomy Tie Pediatric 2cm x 25.5cm (10in) | 2024-03-28 Pediatric Two Piece Trach Ties, 2x25.5cm (10in) - 20/box |