HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102 (UDI Z-0477-2024)
Manufactured by Heartware, Inc.
Device Regulatory Overview
The HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102 (Model/Catalog Number: Unspecified) is a medical device manufactured by Heartware, Inc.. This product is indexed under FDA Product Code / Category Classification Serial numbers: HW1000, HW1001, HW1002, HW1003, HW1006, HW1007, HW1008, HW1010, HW1011, HW1013, HW1017, HW1018, HW1019, HW1026, HW1027, HW1029, HW1030, HW1034, HW1035, HW1037, HW1038, HW1040, HW1044, HW1053, HW1054, HW1055, HW1056, HW1057, HW1058, HW1059, HW1061, HW1062, HW1063, HW1064, HW1065, HW1066, HW1067, HW1068, HW1076, HW1078, HW1093, HW1094, HW1095, HW1096, HW1097, HW1099, HW1100, HW1101, HW1102, HW1103, HW1104, HW1106, HW1107, HW1108, HW1109, HW1110, HW1112, HW1114, HW1115, HW1116, HW1117, HW1118, HW1119, HW1125, HW1126, HW1127, HW1128, HW1129, HW1130, HW1131, HW1132, HW1133, HW1134, HW1135, HW1136, HW1149, HW1150, HW1151, HW1152, HW1153, HW1154, HW1156, HW1158, HW1160, HW1161, HW1162, HW1163, HW1164, HW1165, HW1166, HW1167, HW1168, HW1169, HW1170, HW1172, HW1173, HW1174, HW1175, HW1176, HW1178, HW1179, HW1180, HW1181, HW1182, HW1186, HW1187, HW1188, HW1189, HW1190, HW1191, HW1192, HW1193, HW1195, HW1196, HW1198, HW1199, HW1212, HW1213, HW1214, HW1215, HW1216, HW1217, HW1218, HW1219, HW1220, HW1221, HW1223, HW1225, HW1226, HW1228, HW1231, HW1233, HW1234, HW1235, HW1236, HW1255, HW1256, HW1260, HW1270, HW1271, HW1272, HW1274, HW1275, hw1279, HW1285, HW1286, HW1287, HW1288, HW1289, HW1290, HW1291, HW1294, HW1295, HW1296, HW1298, HW1299, HW1302, HW1303, HW1304, HW1312, HW1313, HW1314, HW1315, HW1316, HW1317, HW1318, HW1344, HW1346, HW1347, HW1348, HW1349, HW1350, HW1351, HW1352, HW1353, HW1355, HW1357, HW1360, HW1361, HW1362, HW1363, HW1364, HW1365, HW1368, HW1369, HW1370, HW1371, HW1372, hw1373, HW1402, HW1405, HW1406, HW1407, HW1408, HW1409, HW1418, HW1419, HW1422, HW1423, HW1424, HW1438, HW1442, HW1443, HW1444, HW1445, HW1446, HW1448, HW1450, HW1453, HW1455, HW1458, HW1459, HW1463, HW1464, HW1468, HW1469, HW1470, HW1471, HW1473, HW1474, HW1475, HW1476, HW1477, HW1478, HW1479, HW1480, HW1481, HW1482, HW1483, HW1484, HW1485, hw1486, hw1487, HW1489, HW1491, HW1492, HW1497, HW1498, HW1499, HW1501, HW1502, HW1503, hw1506, HW1507, HW1508, HW1509, HW1511, HW1513, HW1514, HW1515, HW1516, HW1520, HW1522, HW1525, HW1526, HW1527, HW1530, HW1536, HW1537, HW1538, HW1539, HW1540, HW1542, HW1544, HW1545, HW1546, HW1547, hw1549, HW1550, HW1551, HW1552, HW1558, HW1560, HW1561, HW1563, HW1566, HW1567, HW1568, HW1569, HW1570, HW1571, HW1575, HW1579, HW1580, HW1581, HW1582, HW1583, HW1585, HW1586, HW1587, HW1588, HW1590, HW1591, HW1592, HW1594, HW1595, HW1596, HW1597, HW1600, HW1601, HW1602, HW1603, HW1604, HW1605, HW1607, HW1609, HW1610, HW1611, HW1614, HW1615, HW1616, HW1617, HW1619, HW1620, HW1621, HW1624, HW1625, HW1626, HW1631, HW1639, HW1643, HW1644, HW1645, HW1646, HW1647, HW1648, HW1649, HW1650, HW1651, HW1652, HW1653, HW1654, HW1655, HW1656, HW1657, HW1658, HW1659, HW1660, HW1665, HW1666, HW1667, HW1669, HW1670, HW1671, HW1672, HW1674, HW1675, HW1676, HW1678, HW1679, HW1680, HW1683, HW1685, HW1686, HW1700, HW1703, HW1704, HW1705, HW1707, HW1710, HW1711, HW1712, HW1713, HW1714, HW1715, HW1717, HW1719, HW1720, HW1721, HW1731, HW1736, HW1738, HW1739, HW1742, HW1749, HW1751, HW1752, HW1755, HW1756, HW1779, HW1780, HW1781, HW1782, HW1784, HW1786, HW1787, HW1788, HW1789, HW1791, hw1793, HW1795, HW1797, HW1798, HW1799, HW1800, HW1802, HW1806, HW1807, HW1809, HW1814, HW1829, HW1833, HW1834, HW1835, HW1836, HW1837, HW1838, HW1840, HW1842, HW1846, HW1847, HW1849, HW1854, HW1860, HW1861, HW1863, HW1866, HW1867, HW1868, HW1871, HW1875, HW1880, HW1909, HW1910, HW1911, HW1916, HW1918, HW1932, HW1945, HW1946, HW1948, HW1949, HW1953, HW1954, HW1956, HW1957, HW1958, HW1959, HW1975, HW1980, HW1981, HW1982, HW1984, HW1985, HW1986, HW1988, HW1989, HW1990, HW1991, HW1992, HW1993, HW1994, HW1995, HW2020, HW2021, HW2022, HW2024, HW2025, HW234, HW237, HW238, HW241, HW243, HW244, HW245, HW246, HW248, HW265, HW267, HW268, HW271, HW272, HW273, HW275, HW276, HW283, HW287, HW288, HW289, hw291, HW293, HW294, HW295, HW301, HW302, HW306, HW307, HW308, HW309, HW311, HW312, HW318, HW326, HW327, HW332, HW333, HW334, HW340, HW341, HW342, HW343, HW349, HW350, HW352, HW354, HW355, HW356, HW357, HW358, HW359, HW360, HW361, HW362, HW364, HW365, HW367, HW368, HW370, HW372, HW373, HW374, HW375, HW376, HW386, HW388, HW389, HW391, hw393, HW394, HW396, HW407, HW408, HW411, HW412, HW413, HW414, HW423, HW424, HW432, HW434, HW435, HW437, HW438, HW439, HW445, HW448, HW449, HW451, HW453, HW457, HW458, HW459, HW460, HW461, HW462, HW463, HW464, hw465, HW470, HW471, HW472, HW473, HW476, HW477, HW480, HW483, HW485, HW487, HW489, HW491, HW493, HW495, HW496, HW499, HW502, HW503, HW504, HW507, HW508, HW509, HW510, HW511, HW512, HW513, HW514, hw515, HW516, HW517, HW518, HW519, HW520, HW521, HW522, HW523, HW524, HW537, HW538, HW539, hw540, HW541, HW542, HW543, HW544, HW545, HW546, HW547, HW548, HW549, HW550, hw551, hw552, HW553, HW554, HW558, HW559, HW565, HW569, HW570, hw571, HW572, HW573, HW574, HW576, HW579, HW580, HW582, HW586, HW587, HW588, HW589, HW593, HW594, HW595, HW596, HW597, HW598, HW599, HW604, HW606, HW607, HW611, HW612, HW613, HW614, HW615, HW616, HW617, HW618, HW619, HW621, HW624, HW625, HW630, HW631, HW632, HW634, HW637, HW639, HW641, HW647, HW649, HW651, HW652, HW653, HW654, HW655, HW656, HW657, HW664, HW665, HW666, HW667, HW668, HW669, HW671, HW673, HW674, HW675, HW676, HW679, HW681, HW682, HW684, HW685, HW686, HW687, HW688, HW689, HW690, HW695, HW696, HW697, HW698, HW699, HW700, HW701, HW703, HW704, HW705, HW707, HW708, HW709, HW710, HW711, HW712, HW713, HW714, HW715, HW716, HW717, HW718, HW719, HW720, HW721, HW722, HW723, HW724, HW725, HW726, HW727, HW728, HW729, HW730, HW731, HW732, HW733, HW735, HW736, HW737, HW738, HW740, HW742, HW743, HW744, HW745, HW746, HW747, HW750, HW751, HW752, HW753, HW754, HW755, HW756, HW757, HW758, HW759, HW760, HW761, HW762, HW763, HW765, HW766, HW767, HW769, HW771, HW772, HW773, HW774, HW775, HW776, HW777, HW778, HW779, HW780, HW781, HW782, HW783, HW784, HW791, HW792, HW793, HW794, HW800, HW802, HW804, HW805, HW806, HW807, HW808, HW809, HW810, HW811, HW813, HW828, HW829, HW830, HW831, HW832, HW833, HW834, HW836, HW837, HW838, HW839, HW840, HW841, HW842, HW843, HW844, HW845, HW846, HW847, HW848, HW849, HW851, HW852, HW853, HW854, HW855, HW856, HW862, HW868, HW869, HW870, HW871, HW872, HW873, HW874, HW875, HW876, HW878, HW880, HW881, HW882, HW883, HW884, HW892, HW893, HW894, HW895, HW896, HW897, HW898, HW899, HW900, HW902, HW903, HW904, HW905, HW906, HW907, HW908, HW909, HW910, HW912, HW913, HW914, HW915, HW916, HW918, HW924, HW925, HW927, HW929, HW934, HW937, HW938, HW940, HW941, HW942, HW944, HW945, HW946, HW948, HW949, HW950, HW951, HW952, HW953, HW954, HW955, HW956, HW981, HW982, HW983, HW984, HW985, HW986, HW987, HW988, HW989, HW990, HW991, HW992, HW993, HW994, HW995, HW996, HW997, HW998, HW999 within international Unique Device Identification (UDI) compliance databases.
Enforcement actions are currently active for this product line.
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Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
Unlock Compliance Data & Serialization Specs
Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.
Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102?
The registered manufacturer of record for HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102 is Heartware, Inc..
What is the Primary UDI-DI identifier for HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is Z-0477-2024.
What classification code is assigned to this device?
This device is registered under product classification code Serial numbers: HW1000, HW1001, HW1002, HW1003, HW1006, HW1007, HW1008, HW1010, HW1011, HW1013, HW1017, HW1018, HW1019, HW1026, HW1027, HW1029, HW1030, HW1034, HW1035, HW1037, HW1038, HW1040, HW1044, HW1053, HW1054, HW1055, HW1056, HW1057, HW1058, HW1059, HW1061, HW1062, HW1063, HW1064, HW1065, HW1066, HW1067, HW1068, HW1076, HW1078, HW1093, HW1094, HW1095, HW1096, HW1097, HW1099, HW1100, HW1101, HW1102, HW1103, HW1104, HW1106, HW1107, HW1108, HW1109, HW1110, HW1112, HW1114, HW1115, HW1116, HW1117, HW1118, HW1119, HW1125, HW1126, HW1127, HW1128, HW1129, HW1130, HW1131, HW1132, HW1133, HW1134, HW1135, HW1136, HW1149, HW1150, HW1151, HW1152, HW1153, HW1154, HW1156, HW1158, HW1160, HW1161, HW1162, HW1163, HW1164, HW1165, HW1166, HW1167, HW1168, HW1169, HW1170, HW1172, HW1173, HW1174, HW1175, HW1176, HW1178, HW1179, HW1180, HW1181, HW1182, HW1186, HW1187, HW1188, HW1189, HW1190, HW1191, HW1192, HW1193, HW1195, HW1196, HW1198, HW1199, HW1212, HW1213, HW1214, HW1215, HW1216, HW1217, HW1218, HW1219, HW1220, HW1221, HW1223, HW1225, HW1226, HW1228, HW1231, HW1233, HW1234, HW1235, HW1236, HW1255, HW1256, HW1260, HW1270, HW1271, HW1272, HW1274, HW1275, hw1279, HW1285, HW1286, HW1287, HW1288, HW1289, HW1290, HW1291, HW1294, HW1295, HW1296, HW1298, HW1299, HW1302, HW1303, HW1304, HW1312, HW1313, HW1314, HW1315, HW1316, HW1317, HW1318, HW1344, HW1346, HW1347, HW1348, HW1349, HW1350, HW1351, HW1352, HW1353, HW1355, HW1357, HW1360, HW1361, HW1362, HW1363, HW1364, HW1365, HW1368, HW1369, HW1370, HW1371, HW1372, hw1373, HW1402, HW1405, HW1406, HW1407, HW1408, HW1409, HW1418, HW1419, HW1422, HW1423, HW1424, HW1438, HW1442, HW1443, HW1444, HW1445, HW1446, HW1448, HW1450, HW1453, HW1455, HW1458, HW1459, HW1463, HW1464, HW1468, HW1469, HW1470, HW1471, HW1473, HW1474, HW1475, HW1476, HW1477, HW1478, HW1479, HW1480, HW1481, HW1482, HW1483, HW1484, HW1485, hw1486, hw1487, HW1489, HW1491, HW1492, HW1497, HW1498, HW1499, HW1501, HW1502, HW1503, hw1506, HW1507, HW1508, HW1509, HW1511, HW1513, HW1514, HW1515, HW1516, HW1520, HW1522, HW1525, HW1526, HW1527, HW1530, HW1536, HW1537, HW1538, HW1539, HW1540, HW1542, HW1544, HW1545, HW1546, HW1547, hw1549, HW1550, HW1551, HW1552, HW1558, HW1560, HW1561, HW1563, HW1566, HW1567, HW1568, HW1569, HW1570, HW1571, HW1575, HW1579, HW1580, HW1581, HW1582, HW1583, HW1585, HW1586, HW1587, HW1588, HW1590, HW1591, HW1592, HW1594, HW1595, HW1596, HW1597, HW1600, HW1601, HW1602, HW1603, HW1604, HW1605, HW1607, HW1609, HW1610, HW1611, HW1614, HW1615, HW1616, HW1617, HW1619, HW1620, HW1621, HW1624, HW1625, HW1626, HW1631, HW1639, HW1643, HW1644, HW1645, HW1646, HW1647, HW1648, HW1649, HW1650, HW1651, HW1652, HW1653, HW1654, HW1655, HW1656, HW1657, HW1658, HW1659, HW1660, HW1665, HW1666, HW1667, HW1669, HW1670, HW1671, HW1672, HW1674, HW1675, HW1676, HW1678, HW1679, HW1680, HW1683, HW1685, HW1686, HW1700, HW1703, HW1704, HW1705, HW1707, HW1710, HW1711, HW1712, HW1713, HW1714, HW1715, HW1717, HW1719, HW1720, HW1721, HW1731, HW1736, HW1738, HW1739, HW1742, HW1749, HW1751, HW1752, HW1755, HW1756, HW1779, HW1780, HW1781, HW1782, HW1784, HW1786, HW1787, HW1788, HW1789, HW1791, hw1793, HW1795, HW1797, HW1798, HW1799, HW1800, HW1802, HW1806, HW1807, HW1809, HW1814, HW1829, HW1833, HW1834, HW1835, HW1836, HW1837, HW1838, HW1840, HW1842, HW1846, HW1847, HW1849, HW1854, HW1860, HW1861, HW1863, HW1866, HW1867, HW1868, HW1871, HW1875, HW1880, HW1909, HW1910, HW1911, HW1916, HW1918, HW1932, HW1945, HW1946, HW1948, HW1949, HW1953, HW1954, HW1956, HW1957, HW1958, HW1959, HW1975, HW1980, HW1981, HW1982, HW1984, HW1985, HW1986, HW1988, HW1989, HW1990, HW1991, HW1992, HW1993, HW1994, HW1995, HW2020, HW2021, HW2022, HW2024, HW2025, HW234, HW237, HW238, HW241, HW243, HW244, HW245, HW246, HW248, HW265, HW267, HW268, HW271, HW272, HW273, HW275, HW276, HW283, HW287, HW288, HW289, hw291, HW293, HW294, HW295, HW301, HW302, HW306, HW307, HW308, HW309, HW311, HW312, HW318, HW326, HW327, HW332, HW333, HW334, HW340, HW341, HW342, HW343, HW349, HW350, HW352, HW354, HW355, HW356, HW357, HW358, HW359, HW360, HW361, HW362, HW364, HW365, HW367, HW368, HW370, HW372, HW373, HW374, HW375, HW376, HW386, HW388, HW389, HW391, hw393, HW394, HW396, HW407, HW408, HW411, HW412, HW413, HW414, HW423, HW424, HW432, HW434, HW435, HW437, HW438, HW439, HW445, HW448, HW449, HW451, HW453, HW457, HW458, HW459, HW460, HW461, HW462, HW463, HW464, hw465, HW470, HW471, HW472, HW473, HW476, HW477, HW480, HW483, HW485, HW487, HW489, HW491, HW493, HW495, HW496, HW499, HW502, HW503, HW504, HW507, HW508, HW509, HW510, HW511, HW512, HW513, HW514, hw515, HW516, HW517, HW518, HW519, HW520, HW521, HW522, HW523, HW524, HW537, HW538, HW539, hw540, HW541, HW542, HW543, HW544, HW545, HW546, HW547, HW548, HW549, HW550, hw551, hw552, HW553, HW554, HW558, HW559, HW565, HW569, HW570, hw571, HW572, HW573, HW574, HW576, HW579, HW580, HW582, HW586, HW587, HW588, HW589, HW593, HW594, HW595, HW596, HW597, HW598, HW599, HW604, HW606, HW607, HW611, HW612, HW613, HW614, HW615, HW616, HW617, HW618, HW619, HW621, HW624, HW625, HW630, HW631, HW632, HW634, HW637, HW639, HW641, HW647, HW649, HW651, HW652, HW653, HW654, HW655, HW656, HW657, HW664, HW665, HW666, HW667, HW668, HW669, HW671, HW673, HW674, HW675, HW676, HW679, HW681, HW682, HW684, HW685, HW686, HW687, HW688, HW689, HW690, HW695, HW696, HW697, HW698, HW699, HW700, HW701, HW703, HW704, HW705, HW707, HW708, HW709, HW710, HW711, HW712, HW713, HW714, HW715, HW716, HW717, HW718, HW719, HW720, HW721, HW722, HW723, HW724, HW725, HW726, HW727, HW728, HW729, HW730, HW731, HW732, HW733, HW735, HW736, HW737, HW738, HW740, HW742, HW743, HW744, HW745, HW746, HW747, HW750, HW751, HW752, HW753, HW754, HW755, HW756, HW757, HW758, HW759, HW760, HW761, HW762, HW763, HW765, HW766, HW767, HW769, HW771, HW772, HW773, HW774, HW775, HW776, HW777, HW778, HW779, HW780, HW781, HW782, HW783, HW784, HW791, HW792, HW793, HW794, HW800, HW802, HW804, HW805, HW806, HW807, HW808, HW809, HW810, HW811, HW813, HW828, HW829, HW830, HW831, HW832, HW833, HW834, HW836, HW837, HW838, HW839, HW840, HW841, HW842, HW843, HW844, HW845, HW846, HW847, HW848, HW849, HW851, HW852, HW853, HW854, HW855, HW856, HW862, HW868, HW869, HW870, HW871, HW872, HW873, HW874, HW875, HW876, HW878, HW880, HW881, HW882, HW883, HW884, HW892, HW893, HW894, HW895, HW896, HW897, HW898, HW899, HW900, HW902, HW903, HW904, HW905, HW906, HW907, HW908, HW909, HW910, HW912, HW913, HW914, HW915, HW916, HW918, HW924, HW925, HW927, HW929, HW934, HW937, HW938, HW940, HW941, HW942, HW944, HW945, HW946, HW948, HW949, HW950, HW951, HW952, HW953, HW954, HW955, HW956, HW981, HW982, HW983, HW984, HW985, HW986, HW987, HW988, HW989, HW990, HW991, HW992, HW993, HW994, HW995, HW996, HW997, HW998, HW999.
Other Devices by Heartware, Inc.
- → STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101
- → 1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLIN
- → HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model Number 1205
- → HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint