| Primary Device ID | 00840117344198 |
| NIH Device Record Key | e2a1a9f5-91fd-4290-bcf0-e46bd5237528 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Resp-O2 Vortex 72 Closed Suction Tracheal Catheter, 16 FR (5.3 mm),30.5 cm/12 in |
| Version Model Number | 31017 |
| Company DUNS | 008124539 |
| Company Name | Dynarex Corporation |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840117343863 [Package] Contains: 00840117344020 Package: Case [2 Units] In Commercial Distribution |
| GS1 | 00840117344020 [Package] Package: Box [10 Units] In Commercial Distribution |
| GS1 | 00840117344198 [Primary] |
| BSY | Catheters, Suction, Tracheobronchial |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-01-13 |
| Device Publish Date | 2026-01-05 |
| 00840117344198 | Double Swivel Elbow (DSE), Tracheal, Adult CONTENTS: 1. Closed Suction Catheter (Adult), 1. MDI |
| 00840117344150 | T-Piece, Tracheal, Adult, STERILE-EO CONTENT: 1. Closed Suction Catheter (Adult), 1. MDI Adaptor |