| Primary Device ID | 00810988020972 |
| NIH Device Record Key | 245b869a-d719-4b15-891c-3ab6e2ee6fd7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 12 F DUO-FLOW AND 14F DUO-FLOW 400XL CATHETER (SCHON XL/FEMORAL SIDEBYSIDE) |
| Version Model Number | JT031402001 |
| Company DUNS | 079506014 |
| Company Name | JET MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810988020972 [Primary] |
| GS1 | 50810988020977 [Package] Package: Box [10 Units] In Commercial Distribution |
| MPB | Catheter, Hemodialysis, Non-Implanted |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-06-20 |
| 50810988021509 - MICRO-STICK SET | 2020-02-03 5F STIFF MICRO-STICK® INTRODUCER SET WITH NITINOL GUIDEWIRE, 4CM NEEDLE |
| 50810988021608 - N/A | 2019-12-05 6.6F PLASTIC ELLIPTIPORT MID-SIZED CT PORT W/ATTACHABLE CHRONOFLEX® POLYURETHANE CATHETER |
| 50810988021196 - MEDCOMP GEN III POWER INJECTABLE PORT | 2019-12-05 6.6F PLASTIC ELLIPTIPORT MID-SIZED CT PORT W/ATTACHABLE CHRONOFLEX® POLYURETHANE CATHETER |
| 50810988021202 - MEDCOMP GEN III POWER INJECTABLE PORT | 2019-12-05 8F PLASTIC ELLIPTIPORT MID-SIZED CT PORT W/ATTACHABLE CHRONOFLEX® POLYURETHANE CATHETER |
| 50810988021219 - MEDCOMP GEN III POWER INJECTABLE PORT | 2019-12-05 6.6F PLASTIC DURAPORT LOW PROFILE CT PORT W/ATTACHABLE CHRONOFLEX® POLYURETHANE CATHETER |
| 50810988021226 - MEDCOMP GEN III POWER INJECTABLE PORT | 2019-12-05 8F PLASTIC DURAPORT LOW PROFILE CT PORT W/ATTACHABLE CHRONOFLEX® POLYURETHANE CATHETER |
| 50810988021615 - N/A | 2019-11-29 8F PLASTIC ELLIPTIPORT MID-SIZED CT PORT W/ATTACHABLE CHRONOFLEX® POLYURETHANE CATHETER |
| 50810988021622 - N/A | 2019-11-29 6.6F PLASTIC DURAPORT LOW PROFILE CT PORT W/ATTACHABLE CHRONOFLEX® POLYURETHANE CATHETER |