| Primary Device ID | 00690103219500 |
| NIH Device Record Key | 7d36b694-6d9a-4a82-a2ca-162094acbc55 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Edwards Reusable Rail |
| Version Model Number | 10000RL |
| Catalog Number | 10000RL |
| Company DUNS | 134139174 |
| Company Name | Edwards Lifesciences LLC |
| Device Count | 1 |
| DM Exempt | true |
| 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 | 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 | |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry place |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00690103219500 [Primary] |
| QWA | Cardiovascular Delivery Catheter System Positioning And Stabilization Device |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00690103219500]
Moist Heat or Steam Sterilization
[00690103219500]
Moist Heat or Steam Sterilization
[00690103219500]
Moist Heat or Steam Sterilization
[00690103219500]
Moist Heat or Steam Sterilization
[00690103219500]
Moist Heat or Steam Sterilization
[00690103219500]
Moist Heat or Steam Sterilization
[00690103219500]
Moist Heat or Steam Sterilization
[00690103219500]
Moist Heat or Steam Sterilization
[00690103219500]
Moist Heat or Steam Sterilization
[00690103219500]
Moist Heat or Steam Sterilization
[00690103219500]
Moist Heat or Steam Sterilization
[00690103219500]
Moist Heat or Steam Sterilization
[00690103219500]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-17 |
| Device Publish Date | 2025-07-09 |