| Primary Device ID | 00643169977822 |
| NIH Device Record Key | 7e2f99c9-34b8-44da-8842-7cf6b0187cf5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Open Pivot™ |
| Version Model Number | 500FA27 |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| 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 |
| Lumen/Inner Diameter | 27 Millimeter |
| Lumen/Inner Diameter | 27 Millimeter |
| Lumen/Inner Diameter | 27 Millimeter |
| Lumen/Inner Diameter | 27 Millimeter |
| Lumen/Inner Diameter | 27 Millimeter |
| Lumen/Inner Diameter | 27 Millimeter |
| Lumen/Inner Diameter | 27 Millimeter |
| Lumen/Inner Diameter | 27 Millimeter |
| Lumen/Inner Diameter | 27 Millimeter |
| Lumen/Inner Diameter | 27 Millimeter |
| Lumen/Inner Diameter | 27 Millimeter |
| Lumen/Inner Diameter | 27 Millimeter |
| Lumen/Inner Diameter | 27 Millimeter |
| Lumen/Inner Diameter | 27 Millimeter |
| Lumen/Inner Diameter | 27 Millimeter |
| Lumen/Inner Diameter | 27 Millimeter |
| Lumen/Inner Diameter | 27 Millimeter |
| Lumen/Inner Diameter | 27 Millimeter |
| Lumen/Inner Diameter | 27 Millimeter |
| Lumen/Inner Diameter | 27 Millimeter |
| Lumen/Inner Diameter | 27 Millimeter |
| Lumen/Inner Diameter | 27 Millimeter |
| Lumen/Inner Diameter | 27 Millimeter |
| Lumen/Inner Diameter | 27 Millimeter |
| Lumen/Inner Diameter | 27 Millimeter |
| Lumen/Inner Diameter | 27 Millimeter |
| Special Storage Condition, Specify | Between 0 and 0 *The storage environment should be clean, cool, and dry. |
| Special Storage Condition, Specify | Between 0 and 0 *The storage environment should be clean, cool, and dry. |
| Special Storage Condition, Specify | Between 0 and 0 *The storage environment should be clean, cool, and dry. |
| Special Storage Condition, Specify | Between 0 and 0 *The storage environment should be clean, cool, and dry. |
| Special Storage Condition, Specify | Between 0 and 0 *The storage environment should be clean, cool, and dry. |
| Special Storage Condition, Specify | Between 0 and 0 *The storage environment should be clean, cool, and dry. |
| Special Storage Condition, Specify | Between 0 and 0 *The storage environment should be clean, cool, and dry. |
| Special Storage Condition, Specify | Between 0 and 0 *The storage environment should be clean, cool, and dry. |
| Special Storage Condition, Specify | Between 0 and 0 *The storage environment should be clean, cool, and dry. |
| Special Storage Condition, Specify | Between 0 and 0 *The storage environment should be clean, cool, and dry. |
| Special Storage Condition, Specify | Between 0 and 0 *The storage environment should be clean, cool, and dry. |
| Special Storage Condition, Specify | Between 0 and 0 *The storage environment should be clean, cool, and dry. |
| Special Storage Condition, Specify | Between 0 and 0 *The storage environment should be clean, cool, and dry. |
| Special Storage Condition, Specify | Between 0 and 0 *The storage environment should be clean, cool, and dry. |
| Special Storage Condition, Specify | Between 0 and 0 *The storage environment should be clean, cool, and dry. |
| Special Storage Condition, Specify | Between 0 and 0 *The storage environment should be clean, cool, and dry. |
| Special Storage Condition, Specify | Between 0 and 0 *The storage environment should be clean, cool, and dry. |
| Special Storage Condition, Specify | Between 0 and 0 *The storage environment should be clean, cool, and dry. |
| Special Storage Condition, Specify | Between 0 and 0 *The storage environment should be clean, cool, and dry. |
| Special Storage Condition, Specify | Between 0 and 0 *The storage environment should be clean, cool, and dry. |
| Special Storage Condition, Specify | Between 0 and 0 *The storage environment should be clean, cool, and dry. |
| Special Storage Condition, Specify | Between 0 and 0 *The storage environment should be clean, cool, and dry. |
| Special Storage Condition, Specify | Between 0 and 0 *The storage environment should be clean, cool, and dry. |
| Special Storage Condition, Specify | Between 0 and 0 *The storage environment should be clean, cool, and dry. |
| Special Storage Condition, Specify | Between 0 and 0 *The storage environment should be clean, cool, and dry. |
| Special Storage Condition, Specify | Between 0 and 0 *The storage environment should be clean, cool, and dry. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169977822 [Primary] |
| LWQ | HEART-VALVE, MECHANICAL |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-01-22 |
| Device Publish Date | 2021-01-14 |
| 00613994869050 | MHV 500DM35 STD MITRAL |
| 00613994869043 | MHV 500FA29 STD AORTIC |
| 00613994869036 | MHV 500FA27 STD AORTIC |
| 00613994869029 | MHV 500FA25 STD AORTIC |
| 00613994869012 | MHV 500FA23 STD AORTIC |
| 00613994869005 | MHV 500FA21 STD AORTIC |
| 00613994868992 | MHV 500FA19 STD AORTIC |
| 00613994868985 | MHV 500DM31 STD MITRAL |
| 00613994868978 | MHV 500DM29 STD MITRAL |
| 00613994868961 | MHV 500DM27 STD MITRAL |
| 00613994868954 | MHV 501DA16 AP AORTIC |
| 00613994868947 | MHV 500DM33 STD MITRAL |
| 00613994868930 | MHV 500DM31 STD MITRAL |
| 00613994868923 | MHV 500DM29 STD MITRAL |
| 00613994868916 | MHV 500DM27 STD MITRAL |
| 00613994868893 | MHV 505DA26 AP360 |
| 00613994868886 | MHV 505DA24 AP360 |
| 00613994868879 | MHV 505DA22 AP360 |
| 00613994868862 | MHV 505DA20 AP360 |
| 00613994868855 | MHV 505DA18 AP360 |
| 00613994868848 | MHV 505DA16 AP360 |
| 00613994868800 | MHV 501DA18 AP AORTIC |
| 00613994868794 | MHV 500DM25 STD MITRAL |
| 00613994868787 | MHV 500FA29 STD AORTIC |
| 00613994868770 | MHV 500FA27 STD AORTIC |
| 00613994868756 | MHV 500FA23 STD AORTIC |
| 00613994868749 | MHV 500FA21 STD AORTIC |
| 00613994868732 | MHV 500FA19 STD AORTIC |
| 00613994868725 | MHV 501DM28 AP MITRAL |
| 00613994868718 | MHV 501DM26 AP MITRAL |
| 00613994868701 | MHV 501DM24 AP MITRAL |
| 00613994868695 | MHV 501DM22 AP MITRAL |
| 00613994868688 | MHV 501DA26 AP AORTIC |
| 00613994868671 | MHV 501DA24 AP AORTIC |
| 00613994868664 | MHV 501DA22 AP AORTIC |
| 00613994868657 | MHV 501DA20 AP AORTIC |
| 00613994868633 | MHV 503DA26 APEX AORTIC |
| 00613994868626 | MHV 503DA24 APEX AORTIC |
| 00613994868619 | MHV 503DA22 APEX AORTIC |
| 00613994868602 | MHV 503DA20 APEX AORTIC |
| 00613994868596 | MHV 503DA18 APEX AORTIC |
| 00613994868589 | MHV 503DA16 APEX AORTIC |
| 00613994868374 | AVG 502AG29 CONDUIT |
| 00613994868367 | AVG 502AG27 CONDUIT |
| 00613994868350 | AVG 502AG25 CONDUIT |
| 00613994868343 | AVG 502AG23 CONDUIT |
| 00613994868336 | AVG 502AG21 CONDUIT |
| 00643169133464 | AVG 502AG21 CONDUIT |
| 00643169133457 | AVG 502AG23 CONDUIT |
| 00643169133440 | AVG 502AG25 CONDUIT |