| Primary Device ID | 00384409005966 |
| NIH Device Record Key | 0619a97b-7272-4cf8-8ddd-67d938742705 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fusion Bioline Supported Vascular Grafts |
| Version Model Number | M00201503048B0 |
| Catalog Number | M00201503048B0 |
| Company DUNS | 022348156 |
| Company Name | MAQUET CARDIOVASCULAR LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 888-880-2874 |
| cssurgery@maquet.com | |
| Phone | 888-880-2874 |
| cssurgery@maquet.com | |
| Phone | 888-880-2874 |
| cssurgery@maquet.com | |
| Phone | 888-880-2874 |
| cssurgery@maquet.com | |
| Phone | 888-880-2874 |
| cssurgery@maquet.com | |
| Phone | 888-880-2874 |
| cssurgery@maquet.com | |
| Phone | 888-880-2874 |
| cssurgery@maquet.com | |
| Phone | 888-880-2874 |
| cssurgery@maquet.com | |
| Phone | 888-880-2874 |
| cssurgery@maquet.com | |
| Phone | 888-880-2874 |
| cssurgery@maquet.com | |
| Phone | 888-880-2874 |
| cssurgery@maquet.com | |
| Phone | 888-880-2874 |
| cssurgery@maquet.com | |
| Phone | 888-880-2874 |
| cssurgery@maquet.com |
| Lumen/Inner Diameter | 8 Millimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 40 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 40 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 40 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 40 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 40 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 40 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 40 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 40 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 40 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 40 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 40 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Length | 40 Centimeter |
| Lumen/Inner Diameter | 8 Millimeter |
| Special Storage Condition, Specify | Between 0 and 0 *Store at Controlled Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at Controlled Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at Controlled Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at Controlled Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at Controlled Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at Controlled Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at Controlled Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at Controlled Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at Controlled Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at Controlled Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at Controlled Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at Controlled Room Temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Store at Controlled Room Temperature |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00384409005966 [Primary] |
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| 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 | 2015-10-24 |
| 00384409006031 | Fusion Bioline 8mm-80cm Supp Peripheral |
| 00384409006024 | Fusion Bioline 7mm-80cm Supp Peripheral |
| 00384409006017 | Fusion Bioline 6mm-80cm Supp Peripheral |
| 00384409006000 | Fusion Bioline 5mm-80cm Supp Peripheral |
| 00384409005997 | Fusion Bioline 10mm-80cm Supp Peripheral |
| 00384409005980 | Fusion Bioline 8mm-60cm Supp Peripheral |
| 00384409005973 | Fusion Bioline 6mm-60cm Supp Peripheral |
| 00384409005966 | Fusion Bioline 8mm-40cm Supp Peripheral |
| 00384409005959 | Fusion Bioline 7mm-40cm Supp Peripheral |
| 00384409005942 | Fusion Bioline 6mm-40cm Supp Peripheral |
| 00384409005935 | Fusion Bioline 5mm-40cm Supp Peripheral |
| 00384409005928 | Fusion Bioline 10mm-40cm Supp Peripheral |