Primary Device ID | 00690103220001 |
NIH Device Record Key | bd2f5020-72df-4570-9c95-ba036dfc443b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Edwards rail tray |
Version Model Number | TRAY10500RL |
Catalog Number | TRAY10500RL |
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 | 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 |
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 | 00690103220001 [Primary] |
QWA | Cardiovascular Delivery Catheter System Positioning And Stabilization Device |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00690103220001]
Moist Heat or Steam Sterilization
[00690103220001]
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 |
00690103219494 - Edwards Reusable Rail Extension | 2025-07-17 Edwards Reusable Rail Extension |
00690103219500 - Edwards Reusable Rail | 2025-07-17 Edwards Reusable Rail |
00690103219562 - Edwards EVOQUE Loading System | 2025-07-17 Edwards EVOQUE Loading System |
00690103219579 - Edwards EVOQUE Stabilizer | 2025-07-17 Edwards EVOQUE Stabilizer |
00690103220001 - Edwards rail tray | 2025-07-17Edwards rail tray |
00690103220001 - Edwards rail tray | 2025-07-17 Edwards rail tray |
00690103220629 - ESHEATH OPTIMA INTRODUCER SET (14F) | 2025-05-15 eSheath Optima Introducer Set (14F) |
00690103217957 - HemoSphere Alta | 2025-03-21 HemoSphere Alta advanced monitor (All-on-one) |
00690103217964 - HemoSphere Alta | 2025-03-21 HemoSphere Alta advanced monitor (Smart Recovery) |