| Primary Device ID | 08717648137754 |
| NIH Device Record Key | 7b9fa713-36ea-44e1-a766-148e2f7c6879 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EMBOSHIELD NAV6 |
| Version Model Number | 22438-19 |
| Catalog Number | 22438-19 |
| Company DUNS | 964569052 |
| Company Name | ABBOTT VASCULAR INC. |
| 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 | false |
| 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)227-9902 |
| AV.CUSTOMERCARE@AV.ABBOTT.COM |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dark area. Do not expose to organic solvents or ionizing radiation. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08717648137754 [Primary] |
| NTE | Temporary Carotid Catheter for Embolic Capture |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-04-09 |
| Device Publish Date | 2016-02-05 |
| 08717648137754 | Emboshield NAV6 Embolic Protection System 7.2 mm x 190 cm |
| 08717648137747 | Emboshield NAV6 Embolic Protection System 5.0 mm x 190 cm |