| Primary Device ID | 20848530082073 |
| NIH Device Record Key | 0dfb3952-d1df-43de-a64f-a3c86c78d7ee |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Suction Catheter Kit - Sterile - Includes Gloves, Catheter - 10Fr |
| Version Model Number | TRATK110 |
| Catalog Number | TRATK110 |
| Company DUNS | 141668116 |
| Company Name | SUNSET HEALTHCARE SOLUTIONS, INC. |
| Device Count | 1 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00848530082079 [Primary] |
| GS1 | 10848530082076 [Package] Contains: 00848530082079 Package: [50 Units] In Commercial Distribution |
| GS1 | 20848530082073 [Package] Contains: 10848530082076 Package: [4 Units] In Commercial Distribution |
| OFS | Tracheal Suction Set |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-18 |
| Device Publish Date | 2018-09-17 |
| 00848530105921 - Filter - Vent | 2025-07-18 Ventec VOCSN Style Patient Air Intake Filter- 25/pack |
| 00848530106416 - Filter - Vent | 2025-07-18 ResMed Astral Style Inlet Filter |
| 00848530106133 - Mobility Support Kit | 2025-07-10 StrongArm Retail Starter Kit This kit contains: 2 each of BM001-BL, BM001-PR, BM001, BM002, BM004, & BM005 |
| 10848530106161 - Tracheostomy and Suction Accessory | 2025-07-10 Neo/Pediatric, 72-Hr, Tracheostomy, Standard CSS, 305mm, MDI Port, 5Fr, Swivel Connectors, Sterile, Latex-Free |
| 10848530106178 - Tracheostomy and Suction Accessory | 2025-07-10 Neo/Pediatric, 72-Hr, Tracheostomy, Standard CSS 305mm, MDI Port, 7Fr, Swivel Connectors, Sterile, Latex-Free |
| 10848530106185 - Tracheostomy and Suction Accessory | 2025-07-10 Neo/Pediatric, 72-Hr, Tracheostomy, Standard CSS, 305mm, MDI Port, 7Fr, Swivel Connectors, Sterile, Latex-Free |
| 10848530106192 - Tracheostomy and Suction Accessory | 2025-07-10 Neo/Pediatric, 72-Hr, Tracheostomy, Standard CSS, 305mm, MDI Port, 8Fr, Swivel Connectors, Sterile, Latex-Free |
| 00848530106300 - Tracheostomy and Suction Accessory | 2025-07-10 Flexible Trach Adapter, 15mm Cuff Comparable to OEM# 1073863 |