| Primary Device ID | 00690103165418 |
| NIH Device Record Key | 1214a57d-d65b-4cbc-9d90-d97d8d93ab7b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FLOTRAC, VIGILEO |
| Version Model Number | APCO9 |
| Catalog Number | APCO9 |
| 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 | 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 |
| Length | 108 Inch |
| Length | 108 Inch |
| 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 | 00690103165418 [Primary] |
| DXG | COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-03 |
| 00690103184976 | CONNECTING CABLE APCO9X2 |
| 00690103165418 | CONNECTING CABLE APCO9 |