| Primary Device ID | B090E20130S1 |
| NIH Device Record Key | 51e709ac-971a-485a-b5c1-436290881f74 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | XO Cath |
| Version Model Number | E20-130-S |
| Catalog Number | E20-130-S |
| Company DUNS | 017535668 |
| Company Name | ZIEN MEDICAL TECHNOLOGIES, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 | true |
| OTC Over-The-Counter | false |
| Catheter Length | 130 Centimeter |
| Catheter Gauge | 2 French |
| Catheter Length | 130 Centimeter |
| Catheter Gauge | 2 French |
| Catheter Length | 130 Centimeter |
| Catheter Gauge | 2 French |
| Catheter Length | 130 Centimeter |
| Catheter Gauge | 2 French |
| Catheter Length | 130 Centimeter |
| Catheter Gauge | 2 French |
| Catheter Length | 130 Centimeter |
| Catheter Gauge | 2 French |
| Catheter Length | 130 Centimeter |
| Catheter Gauge | 2 French |
| Catheter Length | 130 Centimeter |
| Catheter Gauge | 2 French |
| Catheter Length | 130 Centimeter |
| Catheter Gauge | 2 French |
| Catheter Length | 130 Centimeter |
| Catheter Gauge | 2 French |
| Catheter Length | 130 Centimeter |
| Catheter Gauge | 2 French |
| Catheter Length | 130 Centimeter |
| Catheter Gauge | 2 French |
| Catheter Length | 130 Centimeter |
| Catheter Gauge | 2 French |
| Catheter Length | 130 Centimeter |
| Catheter Gauge | 2 French |
| Catheter Length | 130 Centimeter |
| Catheter Gauge | 2 French |
| Catheter Length | 130 Centimeter |
| Catheter Gauge | 2 French |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B090E20130S0 [Primary] |
| HIBCC | B090E20130S1 [Package] Contains: B090E20130S0 Package: Shelf Carton [1 Units] In Commercial Distribution |
| HIBCC | B090E20130S2 [Package] Package: Shipper [10 Units] In Commercial Distribution |
| KRA | Catheter, Continuous Flush |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-08 |
| Device Publish Date | 2024-04-30 |
| B090E20130S1 | The XO Cath microcatheter is intended for peripheral vascular use. The microcatheter can be used |
| B090E20130B1 | The XO Cath microcatheter is intended for peripheral vascular use. The microcatheter can be used |