| Primary Device ID | 00690103192049 |
| NIH Device Record Key | b975cff6-9f98-44d0-92f5-3d8b5960ff03 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ThruPort Systems Embol-X Introducer Sheath |
| Version Model Number | EXIS |
| Catalog Number | EXIS |
| Company DUNS | 134139174 |
| Company Name | Edwards Lifesciences LLC |
| 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 | 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 |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Catheter Gauge | 14 French |
| Special Storage Condition, Specify | Between 0 and 0 *Store sterile packaged product in a cool dry place until ready for use. |
| Special Storage Condition, Specify | Between 0 and 0 *Store sterile packaged product in a cool dry place until ready for use. |
| Special Storage Condition, Specify | Between 0 and 0 *Store sterile packaged product in a cool dry place until ready for use. |
| Special Storage Condition, Specify | Between 0 and 0 *Store sterile packaged product in a cool dry place until ready for use. |
| Special Storage Condition, Specify | Between 0 and 0 *Store sterile packaged product in a cool dry place until ready for use. |
| Special Storage Condition, Specify | Between 0 and 0 *Store sterile packaged product in a cool dry place until ready for use. |
| Special Storage Condition, Specify | Between 0 and 0 *Store sterile packaged product in a cool dry place until ready for use. |
| Special Storage Condition, Specify | Between 0 and 0 *Store sterile packaged product in a cool dry place until ready for use. |
| Special Storage Condition, Specify | Between 0 and 0 *Store sterile packaged product in a cool dry place until ready for use. |
| Special Storage Condition, Specify | Between 0 and 0 *Store sterile packaged product in a cool dry place until ready for use. |
| Special Storage Condition, Specify | Between 0 and 0 *Store sterile packaged product in a cool dry place until ready for use. |
| Special Storage Condition, Specify | Between 0 and 0 *Store sterile packaged product in a cool dry place until ready for use. |
| Special Storage Condition, Specify | Between 0 and 0 *Store sterile packaged product in a cool dry place until ready for use. |
| Special Storage Condition, Specify | Between 0 and 0 *Store sterile packaged product in a cool dry place until ready for use. |
| Special Storage Condition, Specify | Between 0 and 0 *Store sterile packaged product in a cool dry place until ready for use. |
| Special Storage Condition, Specify | Between 0 and 0 *Store sterile packaged product in a cool dry place until ready for use. |
| Special Storage Condition, Specify | Between 0 and 0 *Store sterile packaged product in a cool dry place until ready for use. |
| Special Storage Condition, Specify | Between 0 and 0 *Store sterile packaged product in a cool dry place until ready for use. |
| Special Storage Condition, Specify | Between 0 and 0 *Store sterile packaged product in a cool dry place until ready for use. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00690103192049 [Primary] |
| DYB | INTRODUCER, CATHETER |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-06-07 |
| Device Publish Date | 2016-08-31 |
| 00690103217957 - HemoSphere Alta | 2025-03-21 HemoSphere Alta advanced monitor (All-on-one) |
| 00690103217964 - HemoSphere Alta | 2025-03-21 HemoSphere Alta advanced monitor (Smart Recovery) |
| 00690103217971 - HemoSphere Alta | 2025-03-21 HemoSphere Alta monitor (Cardiac) |
| 00690103217278 - Edwards | 2025-01-15 Edwards Reusable Plate |
| 00690103217292 - Edwards | 2025-01-15 Edwards Reusable Platform |
| 00690103218015 - Edwards | 2025-01-15 Edwards Reusable Cradle |
| 00690103019063 - HEART VALVE HANDLE ACCESSORY | 2024-10-28 HDLE,MITRAL ST/STEEL F/USE W/ 6625 OR 9120R HEART VLV |
| 50690103019242 - DISPOSABLE HANDLE FOR VALVES/SIZERS | 2024-10-28 DISPOSABLE HANDLE FOR VALVES/SIZERS |