| Primary Device ID | B090ASP10401 |
| NIH Device Record Key | 1031dd06-d1c4-4bb9-b2b0-54f92b09b118 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Control 10T Mechanical Thrombectomy System Tubing, Female Suction |
| Version Model Number | ASP-1040 |
| Catalog Number | ASP-1040 |
| Company DUNS | 017535668 |
| Company Name | ZIEN MEDICAL TECHNOLOGIES, 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B090ASP10400 [Primary] |
| HIBCC | B090ASP10401 [Package] Contains: B090ASP10400 Package: Shelf Carton [5 Units] In Commercial Distribution |
| HIBCC | B090ASP10402 [Package] Package: Shipper [2 Units] In Commercial Distribution |
| BYY | Tube, Aspirating, Flexible, Connecting |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-04-05 |
| Device Publish Date | 2023-03-28 |
| B090MT10100F1 | The Control 10T Mechanical Thrombectomy System Tubing, Female Suction is designed to connect a c |
| B090ASP10401 | The Control 10T Mechanical Thrombectomy System Tubing, Female Suction is designed to connect a c |