| Primary Device ID | 00690103194579 |
| NIH Device Record Key | fecad068-e811-46d4-a45f-ad005f7da59f |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | DINAPT |
| Catalog Number | DINAPT |
| Company DUNS | 134139174 |
| Company Name | Edwards Lifesciences LLC |
| Device Count | 2 |
| 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 |
| Outer Diameter | 0.08 Inch |
| Outer Diameter | 0.08 Inch |
| 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 | 00690103194579 [Primary] |
| GS1 | 70690103194578 [Unit of Use] |
| LDF | ELECTRODE, PACEMAKER, TEMPORARY |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-03 |