Smiths Medical ASD, Inc.

Lot numbers: 1638874, 1679973, 1713958, 1733048, 1825909, 1878011, 1671976, 1704652, 1708813, 1770355, 1782865, 1793515, 1782708, 1774658, 1825910, 1796685, 1671995, 1692769, 1687755, 1696907, 1713959, 1774659, 1770356, 1804346, 1896192, 1692770, 1704653, 1725263, 1757829, 1766337, 1757828, 1778514, 1774660, and 1814097. Reorder numbers: 60SN025, 60SN030, 60SN035, and 60SN040.

Anesthesiology Devices

2

No

Worldwide Distribution - USA Nationwide: AZ, CA, CO, CT,DE, FL, GA, HI, IL, IN, KS, KY, LA, SC, TX, OR, NJ, MO, UT, MI, NY, NM, MA, MN, MS, NC, ND, NE, NH, NV, OH, OK, OR, RI, SD, TN, VA, VT, WA, WI, WV including Washinton DC, Australia, Austria, Barbados, Belgium, Brazil, Canada, Chile, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Germany, Gibraltar, Great Britain (UK), Greece, Hong Kong, Ireland, Israel, Italy, Kuwait, Libya, Malaysia, Netherlands, New Zeland, Norway, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, United Arab Emirates, United States, Vatican City State

Bivona Uncuffed Neonatal Tracheostomy Tube || Sizes 2.5 - 4.0 (With a Straight Neck Flange) || Product Usage: This tube is intended to provide direct airway access for a tracheostomized patient for up to 29 days. It may be reprocessed up to 5 times for single patient reuse.

Lot numbers: 1642703, 1644867, 1651803, 1663881, 1679949, 1687728, 1721269, 1729063, 1725213, 1741726, 1757813, 1848200, 1856117, 1868242, 1900030, 1631488, 1637935, 1644859, 1655821, 1648159, 1663882, 1671974, 1687729, 1692750, 1704578, 1713917, 1725214, 1745583, 1749519, 1749520, 1793487, 1754748, 1774632, 1835034, 1856118, 1809037, 1864898, 1878000, 1891558, 1900031, 1793488, 1913118, 1634468, 1642799, 1651811, 1648156, 1658726, 1675671, 1679950, 1658986, 1692749, 1687731, 1687730, 1704580, 1721271, 1704581, 1749521, 1745584, 1787318, 1778390, 1778389, 1809040, 1809039, 1809038, 1814074, 1817465, 1793489, 1817466, 1835035, 1848201, 1860825, 1864899, 1883533, 1891559, 1904078, 1914909, 1634469, 1642713, 1648151, 1651824, 1658978, 1667767, 1671996, 1683694, 1696912, 1687732, 1704582, 1716552, 1713918, 1725217, 1725216, 1745585, 1741728, 1749523, 1749524, 1757814, 1770345, 1782688, 1782837, 1814076, 1814075, 1829812, 1842425, 1848202, 1860826, 1878001, and 1896181. Reorder numbers: 60N025, 60N030, 60N035 and 60N040.

Anesthesiology Devices

2

No

Worldwide Distribution - USA Nationwide: AZ, CA, CO, CT,DE, FL, GA, HI, IL, IN, KS, KY, LA, SC, TX, OR, NJ, MO, UT, MI, NY, NM, MA, MN, MS, NC, ND, NE, NH, NV, OH, OK, OR, RI, SD, TN, VA, VT, WA, WI, WV including Washinton DC, Australia, Austria, Barbados, Belgium, Brazil, Canada, Chile, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Germany, Gibraltar, Great Britain (UK), Greece, Hong Kong, Ireland, Israel, Italy, Kuwait, Libya, Malaysia, Netherlands, New Zeland, Norway, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, United Arab Emirates, United States, Vatican City State

Bivona Uncuffed Neonatal Tracheostomy Tube Sizes 2.5 - 4.0 (With a V-Shaped Neck Flange)

Lot numbers: 1692735, 1729051, 1754765, 1770349, 1774642, 1793494, 1848193, 1692736, 1711384, 1729052, 1733036, 1754766, 1766332, 1774644, 1793495, 1835041, 1875197, 1875196, 1890747, 1914913, 1692737, 1721293, 1716571, 1729064, 1737247, 1741741, 1754768, 1759339, 1770350, 1778508, 1825899, 1835042, 1900038, 1638846, 1680978, 1696906, 1721292, 1713934, 1729086, 1757820, 1757821, 1782709, 1782849, 1848183, 1848182, 1913131, 1692739, 1701031, 1708814, 1716572, 1704618, 1713935, 1729065, 1754769, 1745599, 1782710, 1825900, 1851428, 1887772, 1904087, 1692740, 1704619, 1708815, 1729068, 1733034, 1754770, 1766334, 1770351, 1887773, 1692755, 1704620, 1729072, 1754771, 1754772, 1770352, and 1787327. Reorder numbers: 60SP025, 60SP030, 60SP035, 60SP040, 60SP045, 60SP050, and 60SP055.

Anesthesiology Devices

2

No

Worldwide Distribution - USA Nationwide: AZ, CA, CO, CT,DE, FL, GA, HI, IL, IN, KS, KY, LA, SC, TX, OR, NJ, MO, UT, MI, NY, NM, MA, MN, MS, NC, ND, NE, NH, NV, OH, OK, OR, RI, SD, TN, VA, VT, WA, WI, WV including Washinton DC, Australia, Austria, Barbados, Belgium, Brazil, Canada, Chile, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Germany, Gibraltar, Great Britain (UK), Greece, Hong Kong, Ireland, Israel, Italy, Kuwait, Libya, Malaysia, Netherlands, New Zeland, Norway, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, United Arab Emirates, United States, Vatican City State

Bivona Uncuffed Pediatric Tracheostomy Tube Sizes 2.5 - 5.5 (With a Straight Neck Flange) || Product Usage: This tube is intended to provide direct airway access for a tracheostomized patient for up to 29 days. It may be reprocessed up to 5 times for single patient reuse.

Lot numbers: 1636037, 1644866, 1663883, 1679951, 1692748, 1687733, 1704585, 1721276, 1729090, 1749525, 1782855, 1782691, 1774633, 1796667, 1821965, 1848203, 1864900, 1904079, 1919154, 1631500, 1633564, 1644868, 1651808, 1663893, 1642705, 1679952, 1671993, 1683695, 1687734, 1687735, 1721277, 1713919, 1704627, 1725230, 1725229, 1749526, 1745586, 1754752, 1749527, 1774634, 1778472, 1787320, 1793490, 1804335, 1821966, 1829813, 1825890, 1835036, 1848194, 1856122, 1864901, 1883534, 1890739, 1900032, 1908905, 1915878, 1631498, 1639397, 1639396, 1644865, 1644860, 1662327, 1680980, 1651812, 1655834, 1667789, 1671992, 1679954, 1679953, 1701533, 1683697, 1683698, 1687738, 1687739, 1687737, 1692746, 1701028, 1704589, 1704590, 1721278, 1713923, 1721280, 1713920, 1713921, 1704628, 1741730, 1749528, 1745587, 1741732, 1749532, 1749534, 1782848, 1782692, 1793491, 1796668, 1804336, 1821967, 1814077, 1809043, 1817468, 1821968, 1825891, 1829815, 1829814, 1835037, 1838649, 1842426, 1848195, 1851433, 1851427, 1856123, 1860827, 1875189, 1864902, 1875190, 1878002, 1883535, 1887767, 1887765, 1891560, 1896182, 1900033, 1904081, 1904080, 1908906, 1913119, 1914906, 1639399, 1645947, 1639398, 1639403, 1639400, 1639401, 1651807, 1658992, 1663894, 1663887, 1671987, 1672795, 1675700, 1672796, 1671988, 1672797, 1675701, 1671989, 1679955, 1679956, 1683702, 1687740, 1696909, 1704630, 1701029, 1704601, 1713924, 1716557, 1716558, 1704599, 1721282, 1716556, 1713926, 1725236, 1721281, 1749535, 1749536, 1741734, 1745590, 1749538, 1745596, 1749542, 1774636, 1778401, 1774635, 1778402, 1778403, 1770346, 1774637, 1774638, 1778405, 1778404, 1782693, 1782831, 1782695, 1782694, 1782832, 1796671, 1804338, 1814080, 1814078, 1814079, 1817469, 1817470, 1821969, 1796669, 1825893, 1796670, 1829816, 1825892, 1829817, 1838651, 1835038, 1842428, 1842427, 1838650, 1848197, 1848196, 1851431, 1851432, 1856132, 1864905, 1864904, 1856133, 1864903, 1870283, 1860828, 1875191, 1878003, 1878004, 1887768, 1887770, 1887769, 1887771, 1900034, 1891562, 1891561, 1900035, 1904082, 1908907, 1908908, 1913124, 1914908, 1914907, 1913123, 1634471, 1644856, 1644863, 1648165, 1658987, 1655836, 1663891, 1671985, 1679957, 1671984, 1679958, 1683703, 1687741, 1683667, 1687742, 1692743, 1692744, 1701030, 1704609, 1713928, 1713930, 1721286, 1716559, 1713929, 1704610, 1721284, 1749547, 1745594, 1745595, 1749546, 1749549, 1778392, 1741735, 1778391, 1770347, 1778393, 1774639, 1778394, 1782697, 1782820, 1793492, 1796672, 1814081, 1814082, 1809046, 1809045, 1821970, 1817471, 1825894, 1821971, 1829818, 1829819, 1825895, 1835039, 1842429, 1842430, 1848198, 1848188, 1848199, 1851430, 1856134, 1860829, 1860831, 1860830, 1864906, 1875192, 1878005, 1883536, 1883537, 1890745, 1891564, 1891563, 1896183, 1900036, 1904083, 1908909, 1913126, 1913125, 1914911, 1914910, 1631499, 1633566, 1642707, 1642709, 1648158, 1651819, 1655837, 1658982, 1658727, 1680979, 1667788, 1671983, 1679959, 1683706, 1679960, 1683705, 1687744, 1704612, 1704613, 1713931, 1725243, 1716562, 1713932, 1749555, 1749551, 1745592, 1741737, 1749553, 1770348, 1761978, 1749557, 1778421, 1757815, 1782839, 1782698, 1774640, 1778422, 1809047, 1821973, 1825896, 1804339, 1821972, 1796673, 1829820, 1825897, 1821974, 1835040, 1838652, 1842431, 1848189, 1851429, 1860832, 1860833, 1864907, 1870284, 1870285, 1875193, 1878006, 1890746, 1891565, 1891567, 1896184, 1904084, 1908910, 1913127, 1636038, 1642714, 1648154, 1658981, 1663888, 1663895, 1671980, 1679961, 1687745, 1683708, 1704616, 1721288, 1713933, 1704617, 1716563, 1725248, 1761596, 1741739, 1749559, 1749561, 1757818, 1774643, 1782846, 1778426, 1793493, 1796674, 1804340, 1814083, 1829821, 1821976, 1829822, 1821975, 1842432, 1848190, 1856135, 1848191, 1848192, 1856136, 1868252, 1875195, 1875194, 1883538, 1883539, 1891568, 1891569, 1900037, 1904086, 1904085, and 1913128. Reorder numbers: 60P025, 60P030, 60P035, 60P040, 60P045, 60P050, and 60P055.

Anesthesiology Devices

2

No

Worldwide Distribution - USA Nationwide: AZ, CA, CO, CT,DE, FL, GA, HI, IL, IN, KS, KY, LA, SC, TX, OR, NJ, MO, UT, MI, NY, NM, MA, MN, MS, NC, ND, NE, NH, NV, OH, OK, OR, RI, SD, TN, VA, VT, WA, WI, WV including Washinton DC, Australia, Austria, Barbados, Belgium, Brazil, Canada, Chile, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Germany, Gibraltar, Great Britain (UK), Greece, Hong Kong, Ireland, Israel, Italy, Kuwait, Libya, Malaysia, Netherlands, New Zeland, Norway, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, United Arab Emirates, United States, Vatican City State

Bivona Uncuffed Pediatric Tracheostomy Tube Sizes 2.5 - 5.5 (With a V-Shaped Neck Flange) || Product Usage: This tube is intended to provide direct airway access for a tracheostomized patient for up to 29 days. It may be reprocessed up to 5 times for single patient reuse.

Lot numbers: 1692762, 1754787, 1793510, 1817480, 1883552, 1679945, 1692763, 1692764, 1796683, 1793511, 1814096, 1835048, 1848177, 1887782, 1887781, 1631521, 1648147, 1655832, 1671969, 1663886, 1737254, 1725345, 1774655, 1787342, 1825908, 1883553, 1914924, 1692765, 1704648, 1713955, 1729057, 1749590, 1754789, 1804373, 1821991, 1851439, 1856221, 1878010, 1896190, 1913143, 1631522, 1648152, 1683683, 1713956, 1729101, 1848175, 1848176, 1868263, 1875208, 1883555, 1908926, 1919157, 1663878, 1671970, 1687752, 1692766, 1696953, 1708840, 1774656, 1787343, 1793512, 1821992, 1875209, 1868264, 1923407, 1666284, 1683684, 1701033, 1713957, 1749591, 1864913, 1856222, 1883554, 1887783, 1896191, and 1900043.  Reorder numbers: 67SP025, 67SP030, 67SP035, 67SP040, 67SP045, 67SP050, and 67SP055.

Anesthesiology Devices

2

No

Worldwide Distribution - USA Nationwide: AZ, CA, CO, CT,DE, FL, GA, HI, IL, IN, KS, KY, LA, SC, TX, OR, NJ, MO, UT, MI, NY, NM, MA, MN, MS, NC, ND, NE, NH, NV, OH, OK, OR, RI, SD, TN, VA, VT, WA, WI, WV including Washinton DC, Australia, Austria, Barbados, Belgium, Brazil, Canada, Chile, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Germany, Gibraltar, Great Britain (UK), Greece, Hong Kong, Ireland, Israel, Italy, Kuwait, Libya, Malaysia, Netherlands, New Zeland, Norway, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, United Arab Emirates, United States, Vatican City State

Bivona TTS Cuffed Pediatric Tracheostomy Tube || Sizes 2.5 - 5.5 (With a Straight Neck Flange) || Product Usage: This tube is intended to provide direct airway access for a tracheostomized patient for up to 29 days. It may be reprocessed up to 5 times for single patient reuse.