Welch Allyn Protocol, Inc

software versions 2.03, 2.04, 2.05, and 2.06

Cardiovascular Devices

3

No

Worldwide distribution: USA, Guam, Puerto Rico, Canada, Mexico, Andorra, UAE, Afghanistan, Australia, Azerbaijan, Belgium, Belarus, Bermuda, Bahrain, Brazil, British West Indies, Switzerland, China, Cyprus, Czech Republic, Germany, Denmark, Algeria, Egypt, Spain, France, French Guiana, French Lesser Antilles, Greece, Haiti, Hong Kong, Hungary, Ireland, Israel, India, Iraq, Italy, Japan, Kenya, Kyrgyz, Lebanon, Lithuania, Luxembourg, Latvia, Monaco, Malaysia, Netherlands, New Zealand, Phillipines, Pakistan, Poland, Portugal, Reunion Island, Russia, Saudi Arabia, Singapore, South Korea, Taiwan, United Kingdom, Uraguay, Yemen, and South America.

Welch Allyn AED 10 automatic external defibrillator and MRL Jumpstart (collectively "AED 10")

Model Number 65.   System Serial # TA00646 with TA01973, TA00668, TA00668-HA, TA00823, TA00823-HA, TA01968, TA01969, TA01970, TA01971, TA01972, TA01974, TA01975, TA02439, TA02444, and TA02444-HA.  The HA represents High Acuity and is a back-up system connected to the unit with the same number, except for TA00646 which is back up for TA01973. This unit did not originally have a back up and the other unit was not being used so they were combined. The numbers stayed the same for each system for tracking purposes.

Cardiovascular Devices

2

No

Worldwide distribution: (USA) Nationwide distribution including the state of California; and the countries of Singapore; Philippines, France, Italy, Malaysia, Poland, UK, England, UAE, Germany, Spain, Ireland, Portugal, New Zealand, Hong Kong, Thailand, Australia, Canada, and the Netherlands.

Aruba Wireless Network Access Points, Model 65 utilized by the Acuity Central Monitoring System. || Welch Allyn Protocol, Inc. || Intended for use by clinicians for the central monitoring of neonatal, pediatric and adult patients in health care facilities. The system connects to a network of patient monitors to record and analyze physiological data being acquired by the monitors.

Cardiovascular Devices

2

No

Worldwide Distribution - USA (nationwide) and Internationally to United Arab Emirates, Argentina, Australia, Belgium, Brazil, Canada, Switzerland, Chile, China, Columbia, Costa Rica, Czech Republic, Germany, Denmark, Ecuador, Spain, France, United Kingdom, Greece, Hong Kong,Taiwan, Ireland, Italy, Japan, Korea, Republic of, Kuwait, Lithuania, Luxemborg, Mexico, Malaysia, Mozambique, Namibia, Netherlands, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Sierra Leone, El Salvador, Thailand, Turkey, Uganda, Vietnam, Kosovo, and South Africa.

The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. || These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. || intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

Serial number range - 205787 - 208907 (non-contiguous)   205787, 205788, 205789, 205790, 205791, 205793, 205794, 205795, 205796, 205797, 205798, 205799, 205800, 205801, 205802, 205803, 205804, 205805, 205807, 205808, 205809, 205810, 205811, 205812, 205813, 205814, 205815, 205816, 205817, 205818, 205819, 205820, 205821, 205822, 205823, 205824, 205825, 205826, 205827, 205828, 205829, 205830, 205831, 205832, 205833, 205834, 205835, 205836, 205837, 205838, 205839, 205840, 205841, 205842, 205843, 205844, 205845, 205846, 205847, 205848, 205849, 205850, 205851, 205852, 205853, 205854, 205855, 205856, 205857, 205858, 205860, 205861, 205862, 205863, 205864, 205865, 205866, 205867, 205868, 205869, 205870, 205871, 205872, 205873, 205874, 205875, 205876, 205877, 205878, 205879, 205880, 205881, 205882, 205883, 205884, 205885, 205886, 205887, 205888, 205889, 205890, 205891, 205892, 205893, 205894, 205897, 205898, 205899, 205900, 205901, 205902, 205903, 205904, 205905, 205906, 205908, 205909, 205910, 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207339, 207340, 207341, 207342, 207343, 207344, 207345, 207346, 207347, 207348, 207349, 207350, 207351, 207352, 207353, 207354, 207355, 207356, 207357, 207358, 207359, 207360, 207361, 207362, 207363, 207364, 207365, 207366, 207367, 207368, 207369, 207370, 207371, 207372, 207373, 207374, 207375, 207376, 207377, 207378, 207379, 207380, 207381, 207382, 207383, 207384, 207387, 207389, 207390, 207391, 207392, 207393, 207394, 207395, 207396, 207397, 207398, 207399, 207400, 207401, 207402, 207403, 207404, 207405, 207406, 207407, 207408, 207409, 207410, 207411, 207412, 207413, 207414, 207415, 207416, 207417, 207418, 207419, 207420, 207421, 207422, 207423, 207424, 207425, 207426, 207427, 207428, 207429, 207430, 207431, 207432, 207433, 207434, 207435, 207436, 207437, 207438, 207439, 207440, 207442, 207443, 207444, 207445, 207445, 207446, 207447, 207448, 207449, 207450, 207451, 207452, 207453, 207454, 207455, 207456, 207457, 207458, 207459, 207460, 207461, 207462, 207463, 207464, 207465, 207467, 207468, 207469, 207470, 207472, 207473, 207474, 207475, 207476, 207477, 207478, 207479, 207481, 207484, 207485, 207486, 207487, 207492, 207495.   The following serial numbers were added: 205248, 205653, 205654, 205656, 205664, 205665, 205667, 205669, 205678, 205684, 205708, 205719, 205732, 205736, 205760, 205762, 205763, 205764, 205767, 205774, 205775, 205777, 205781, 205782, 205784, 207523, 207526, 207527, 207528, 207529, 207531, 207532, 207533, 207536, 207537, 207543, 207544, 207545, 207546, 207547, 207548, 207549, 207550, 207551, 207553, 207554, 207555, 207556, 207557, 207560, 207561, 207562, 207563, 207564, 207565, 207566, 207567, 207569, 207570, 207571, 207572, 207574, 207576, 207578, 207581, 207582, 207583, 207584, 207585, 207586, 207587, 207588, 207589, 207590, 207592, 207593, 207594, 207595, 207596, 207597, 207598, 207599, 207600, 207601, 207602, 207604, 207605, 207606, 207607, 207608, 207609, 207610, 207612, 207615, 207616, 207617, 207619, 207621, 207623, 207624, 207628, 207637, 207657, 207658, 207749, 207753, 207754, 207756, 207811, 207813, 207822, 207920, 208907, 208949, and 209240.

Cardiovascular Devices

3

No

Worldwide to include USA, Australia, New Zealand, South Africa, China, Hong Kong, Taiwan, Malaysia, Singapore, Phillippines, South Korea, Viet Nam, Egypt, France, Germany, Ireland, India, Israel, Pakistan, Poland, Russia, Saudi Arabia, Switzerland, United Arab Emirates, United Kingdom, Canada, Ecuador, Puerto Rico, and South America.

Welch Allyn AED 20 Automated External Defibrillator; a portable, 12V internal battery powered defibrillator; Manufactured by MRL Inc., A Welch Allyn Company, Buffalo Grove, Illinois; Model AED 20, Catalog Numbers 972213, 972214, 972215, 972216 (Part Numbers 972200E, 972211E, 972212E, 972213E, 972214E, 972215E, 972216E)

Serial numbers: 002664, 002665, 003449, 003875, 003903, 004108, 004126, 005032, 005096, 005097, 005394, 005438, 006297, 006425, 006728, 006730, 007036, 007039, 007041, 007056, 007057, 007418, 007559, 007999, 008021, 008074, 009474, 009501, 010193, 010194, 010196, 010197, 010387, 011026, 011470, 011834, 011936, 012287, 012659, 012859, 013520, 013928, 014655, 014733, 014927, 015154, 015568, 017521, 017683, 018364, 018777, 018941, 019292, 019619, 020422, 020964, 020965, 021543, 021559, 021643, 022509, 022522, 022545, 022546, 022549, 022578, 022579, 022584, 022596, 022597, 022631, 022641, 022654, 023419, 023420, 023421, 023423, 023697, 024000, 025546, 026137, 026878, NA030786, NA031363, NA031533, NA031857, NA032151, NA032179, NA035807002664, 002665, 003449, 003875, 003903, 004108, 004126, 005032, 005096, 005097, 005394, 005438, 006297, 006425, 006728, 006730, 007036, 007039, 007041, 007056, 007057, 007418, 007559, 007999, 008021, 008074, 009474, 009501, 010193, 010194, 010196, 010197, 010387, 011026, 011470, 011834, 011936, 012287, 012659, 012859, 013520, 013928, 014655, 014733, 014927, 015154, 015568, 017521, 017683, 018364, 018777, 018941, 019292, 019619, 020422, 020964, 020965, 021543, 021559, 021643, 022509, 022522, 022545, 022546, 022549, 022578, 022579, 022584, 022596, 022597, 022631, 022641, 022654, 023419, 023420, 023421, 023423, 023697, 024000, 025546, 026137, 026878, NA030786, NA031363, NA031533, NA031857, NA032151, NA032179, and NA035807.

Cardiovascular Devices

3

No

Worldwide distribution: USA, Belgium, Canada, France, Ireland, Israel, Mexico, and United Kingdom.

Welch Allyn AED 10 Automated External Defibrillator