| Primary Device ID | 00690103174779 |
| NIH Device Record Key | 89bd4acd-ebff-46cf-8185-33818a2192e3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HEART VALVE SIZER ACCESSORY |
| Version Model Number | 1130 |
| Catalog Number | 113023MM |
| 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | +1(800)822-9837 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9837 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9837 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9837 |
| tech_support@edwards.com | |
| Phone | +1(800)822-9837 |
| tech_support@edwards.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00690103174779 [Primary] |
| DTI | Sizer, Heart-Valve, Prosthesis |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00690103174779]
Moist Heat or Steam Sterilization
[00690103174779]
Moist Heat or Steam Sterilization
[00690103174779]
Moist Heat or Steam Sterilization
[00690103174779]
Moist Heat or Steam Sterilization
[00690103174779]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-19 |
| Device Publish Date | 2026-02-11 |
| 00690103019254 | CARPENTIER-EDWARDS AORTIC OBTURATOR |
| 00690103019261 | CARPENTIER-EDWARDS AORTIC OBTURATOR |
| 00690103174809 | PERIMOUNT MAGNA SIZER |
| 00690103174793 | PERIMOUNT MAGNA SIZER |
| 00690103174786 | PERIMOUNT MAGNA SIZER |
| 00690103174779 | PERIMOUNT MAGNA SIZER |
| 00690103174762 | PERIMOUNT MAGNA SIZER |
| 00690103174755 | PERIMOUNT MAGNA SIZER |
| 00690103019292 | CARPENTIER-EDWARDS AORTIC OBTURATOR |
| 00690103019285 | CARPENTIER-EDWARDS AORTIC OBTURATOR |
| 00690103019278 | CARPENTIER-EDWARDS AORTIC OBTURATOR |