| Primary Device ID | 50690103197827 |
| NIH Device Record Key | 63aca854-53f2-4428-811c-cd32090cc819 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FloTrac IQ sensor |
| Version Model Number | MHDQ6AZ5 |
| Catalog Number | MHDQ6AZ5 |
| Company DUNS | 134139174 |
| Company Name | Edwards Lifesciences LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9637 |
| tech_support@edwards.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| 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 | 00690103197822 [Primary] |
| GS1 | 50690103197827 [Package] Contains: 00690103197822 Package: Shipper [5 Units] In Commercial Distribution |
| DRS | Transducer, Blood-Pressure, Extravascular |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-11-26 |
| Device Publish Date | 2018-10-25 |
| 50690103198077 | FloTrac IQ sensor |
| 50690103197827 | FloTrac IQ sensor |
| 00690103197808 | FloTrac IQ sensor |