| Primary Device ID | 50690103199012 |
| NIH Device Record Key | c19a5bea-63a7-4617-924d-65dfbd26d0b9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FloTrac, VAMP Optima, TruWave |
| Version Model Number | MHD8VLTW |
| Catalog Number | MHD8VLTW |
| 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 |
| Length | 84 Inch |
| Length | 84 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 | 00690103199017 [Primary] |
| GS1 | 50690103199012 [Package] Contains: 00690103199017 Package: Shipper [5 Units] In Commercial Distribution |
| FPA | Set, Administration, Intravascular |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-11-30 |
| Device Publish Date | 2018-10-30 |
| 50690103200213 | FloTrac sensor with VAMP Optima system and transducer |
| 50690103199012 | FloTrac sensor with VAMP Optima system and transducer |
| 50690103199005 | FloTrac sensor with VAMP Optima system and transducer |