| Primary Device ID | 00690103218558 |
| NIH Device Record Key | 1a065237-5ed3-462e-83fa-9c8df6517600 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PX1800 |
| Version Model Number | 896038023 |
| Catalog Number | 896038023 |
| 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 | false |
| 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 |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00690103218558 [Primary] |
| DXO | Transducer, Pressure, Catheter Tip |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-16 |
| Device Publish Date | 2024-08-08 |
| 00690103218572 | CABLE ASSEMBLY,EW, ROHS |
| 00690103218565 | CABLE ASSY, EW SIEMENS, MDR |
| 00690103218558 | CBL ASSY,12 PIN/KONTRON,ROHS |
| 00690103218541 | CABLE ASSY, 6 PIN/MS3106, MDR |
| 00690103218534 | CABLE ASSY,EW TRUWAVE,ROHS,MDR |