ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH
VITALTEC CORPORATION
VITALTEC CORPORATION
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3040279832 | 3040279832 | VITALTEC CORPORATION | 1 | N | 2026-01-01 | No. 12, Lane 4-30, Chyuan-Zhou Rd., Hou-Li Dist., Taichung TW 42142 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 341930 | 1127087371 | K242921 | 5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 5310600-5311000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Fenestrated, sizes 6.0-10.0mm; 5400600-5401000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, sizes 6.0-10.0mm; 5410500-5411000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, Fenestrated, sizes 6.0-10.0mm | BTO | 2025-06-10 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| BTO | 1 | 2025-06-10 |