| Primary Device ID | 00690103210132 |
| NIH Device Record Key | 36ae6492-4b77-4b41-9713-cdaf1790434a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MITRIS Handle 1140M |
| Version Model Number | 1140M |
| Catalog Number | 1140M |
| Company DUNS | 134139174 |
| Company Name | Edwards Lifesciences LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00690103210132 [Primary] |
| DTJ | Holder, Heart-Valve, Prosthesis |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00690103210132]
Moist Heat or Steam Sterilization
[00690103210132]
Moist Heat or Steam Sterilization
[00690103210132]
Moist Heat or Steam Sterilization
[00690103210132]
Moist Heat or Steam Sterilization
[00690103210132]
Moist Heat or Steam Sterilization
[00690103210132]
Moist Heat or Steam Sterilization
[00690103210132]
Moist Heat or Steam Sterilization
[00690103210132]
Moist Heat or Steam Sterilization
[00690103210132]
Moist Heat or Steam Sterilization
[00690103210132]
Moist Heat or Steam Sterilization
[00690103210132]
Moist Heat or Steam Sterilization
[00690103210132]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-10-28 |
| Device Publish Date | 2024-10-18 |
| 57460691952770 - TRUWAVE | 2026-03-30 PRESSURE MONITORING SET |
| 57460691955887 - TRUWAVE | 2026-03-30 PRESSURE MONITORING SET |
| 00690103000382 - SWAN-GANZ TRUE SIZE | 2026-03-24 SWAN-GANZ TRUE SIZE MONITORING CATHETER DOUBLE LUMEN |
| 50690103218287 - SWAN-GANZ VIP | 2026-03-24 SWAN-GANZ THERMODILUTION VEINOUS FUSION PORT CATHETER |
| 50690103218607 - SWAN-GANZ TRUE SIZE | 2026-03-24 TRUE SIZE THERMODILUTION CATHETER |
| 50690103218621 - SWAN-GANZ TRUE SIZE | 2026-03-24 TRUE SIZE CATHETER DOUBLE LUMEN |
| 50690103218638 - SWAN-GANZ TRUE SIZE | 2026-03-24 TRUE SIZE MONITORING CATHETER TRIPLE LUMEN |
| 00690103221312 - Edwards SAPIEN 3 transcatheter pulmonic valve delivery system | 2026-02-25 Pulmonic Delivery System - 20 mm (Gen 2) (US) |