| Primary Device ID | 00690103043693 |
| NIH Device Record Key | be5da07d-1e17-4fbd-8ae8-4bec3576abc6 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 420804F |
| Catalog Number | 420804F |
| Company DUNS | 134139174 |
| Company Name | Edwards Lifesciences LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| 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 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| 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 | 00690103043693 [Primary] |
| FGE | CATHETER, BILIARY, DIAGNOSTIC |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-03 |