INOMAX DS

Finished Product Serial#. DS20070005 DS20090559 DS20100326 DS20100343 DS20100915 DS20101282 DS20070101 DS20080024 DS20080064 DS20080074 DS20080141 DS20080222 DS20080229 DS20080318 DS20090052 DS20090086 DS20090109 DS20090121 DS20090190 DS20090328 DS20090584 DS20090611 DS20090618 DS20090676 DS20090708 DS20090770 DS20090825 DS20090880 DS20090890 DS20090931 DS20090941 DS20100016 DS20100038 DS20100283 DS20100285 DS20100302 DS20100497 DS20100529 DS20100542 DS20100665 DS20100724 DS20100747 DS20100851 DS20100852 DS20100887 DS20100939 DS20101073 DS20101077 DS20101264 DS20101330 DS20101397 DS20101505 DS20110021 DS20110204 DS20110353 DS20110388 DS20110398 DS20110399 DS20110406 DS20110429 DS20110433 DS20110487 DS20110850 DS20110867 DS20110934 DS20110967 DS20111009 DS20111123 DS20111124 DS20111125 DS20111140 DS20111184 DS20111185 DS20111190 DS20111206 DS20120019 DS20120167 DS20120172 DS20120191 DS20120197 DS20100219 DS20100877 DS20110787 DS20110410 DS20080298 DS20100012 DS20100162 DS20100962 DS20100964 DS20110892 DS20110981 DS20070010 DS20070255 DS20080314 DS20090265 DS20090424 DS20090642 DS20090661 DS20090889 DS20100036 DS20100583 DS20101157 DS20101214 DS20101478 DS20111200 DS20120041 DS20070041 DS20090013 DS20090028 DS20090034 DS20090647 DS20090923 DS20100395 DS20100443 DS20101226 DS20101314 DS20101396 DS20101482 DS20101523 DS20111029 DS20111057 DS20111091 DS20111120 DS20120047 DS20120049

Anesthesiology Devices

2

No

Distribution US nationwide, including AZ, CA, CT, FL, ID, LA, MD, MI, MS, NH, NJ, NV, NY, OK, PA, TX, UT, VA, WV.

Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with ventilators.

Serial Numbers: DS20070030, DS20070043, DS20070094, DS20070268, DS20090096, DS20090458, DS20090484, DS20090539, DS20090620, DS20090645, DS20100071, DS20100118, DS20100216, DS20100266, DS20100268, DS20100330, DS20100439, DS20100496, DS20100604, DS20100675, DS20100744, DS20100762, DS20100950, DS20101199, DS20101337, DS20101359, DS20101369, DS20101406, DS20101443, DS20101524, DS20110242, DS20110480, DS20110577, DS20110849, DS20110868, DS20110912, DS20110915, DS20110972, DS20110976, DS20110990, DS20120008, DS20120161, DS20120266, DS20120281, DS20120370.

Anesthesiology Devices

2

No

US Distribution to the states of : CA, CO, DC, FL, GA, HI, IA, IL, IN, MI, MN, NC, NJ, NM, NY, OH, PA, and TX

Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery system. Model 10007. Delivers INOMAX (nitric oxide for inhalation). || The INOmax DSIR uses a dual-channel design to ensure the safe delivery of INOMAX. The first channel has the delivery CPU, the flow controller and the injector module to ensure the accurate delivery of NO. The second channel is the monitoring system, which includes a separate monitor CPU, the gas cells (NO, NO2, and 02 cells) and the user interface including the display and alarms. The dual-channel approach to delivery and monitoring permits INOMAX delivery independent of monitoring but also allows the monitoring system to shutdown INOMAX delivery if it detects a fault in the delivery system such that the NO concentration could become greater than 100 ppm. The delivery system can also shut down delivery if it detects certain serious problems with the monitoring system.

Serial Number DS20070005 DS20070006 DS20070007 DS20070008 DS20070009 DS20070010 DS20070011 DS20070012 DS20070013 DS20070014 DS20070015 DS20070016 DS20070017 DS20070018 DS20070019 DS20070020 DS20070021 DS20070022 DS20070023 DS20070024 DS20070025 DS20070026 DS20070027 DS20070028 DS20070029 DS20070030 DS20070031 DS20070032 DS20070033 DS20070034 DS20070035 DS20070036 DS20070037 DS20070038 DS20070039 DS20070040 DS20070041 DS20070042 DS20070043 DS20070044 DS20070045 DS20070046 DS20070047 DS20070048 DS20070049 DS20070050 DS20070051 DS20070052 DS20070053 DS20070054 DS20070055 DS20070056 DS20070057 DS20070058 DS20070059 DS20070060 DS20070061 DS20070062 DS20070063 DS20070064 DS20070065 DS20070066 DS20070067 DS20070068 DS20070069 DS20070070 DS20070071 DS20070072 DS20070073 DS20070074 DS20070075 DS20070076 DS20070077 DS20070078 DS20070079 DS20070080 DS20070081 DS20070082 DS20070083 DS20070084 DS20070085 DS20070086 DS20070087 DS20070091 DS20070092 DS20070093 DS20070094 DS20070095 DS20070096 DS20070097 DS20070098 DS20070099 DS20070100 DS20070101 DS20070102 DS20070103 DS20070104 DS20070105 DS20070106 DS20070107 DS20070108 DS20070109 DS20070110 DS20070111 DS20070112 DS20070113 DS20070114 DS20070115 DS20070116 DS20070117 DS20070118 DS20070119 DS20070120 DS20070121 DS20070122 DS20070123 DS20070124 DS20070125 DS20070126 DS20070127 DS20070128 DS20070129 DS20070130 DS20070131 DS20070132 DS20070133 DS20070134 DS20070135 DS20070136 DS20070137 DS20070138 DS20070139 DS20070140 DS20070141 DS20070142 DS20070143 DS20070144 DS20070145 DS20070146 DS20070147 DS20070148 DS20070149 DS20070150 DS20070151 DS20070152 DS20070153 DS20070154 DS20070155 DS20070156 DS20070157 DS20070158 DS20070159 DS20070160 DS20070161 DS20070162 DS20070163 DS20070164 DS20070165 DS20070166 DS20070167 DS20070168 DS20070169 DS20070170 DS20070171 DS20070172 DS20070173 DS20070174 DS20070175 DS20070176 DS20070177 DS20070178 DS20070179 DS20070180 DS20070181 DS20070182 DS20070183 DS20070184 DS20070185 DS20070186 DS20070187 DS20070188 DS20070189 DS20070190 DS20070191 DS20070192 DS20070193 DS20070194 DS20070195 DS20070196 DS20070197 DS20070198 DS20070200 DS20070201 DS20070202 DS20070203 DS20070204 DS20070205 DS20070206 DS20070207 DS20070208 DS20070209 DS20070210 DS20070211 DS20070212 DS20070213 DS20070214 DS20070215 DS20070216 DS20070217 DS20070218 DS20070219 DS20070220 DS20070221 DS20070222 DS20070223 DS20070224 DS20070225 DS20070226 DS20070227 DS20070229 DS20070230 DS20070231 DS20070232 DS20070233 DS20070234 DS20070235 DS20070236 DS20070237 DS20070238 DS20070239 DS20070240 DS20070241 DS20070242 DS20070243 DS20070244 DS20070245 DS20070247 DS20070248 DS20070249 DS20070250 DS20070251 DS20070252 DS20070253 DS20070254 DS20070255 DS20070256 DS20070257 DS20070258 DS20070259 DS20070260 DS20070261 DS20070262 DS20070263 DS20070264 DS20070265 DS20070266 DS20070267 DS20070268 DS20070269 DS20070270 DS20070271 DS20070272 DS20070274 DS20070275 DS20070276 DS20070277 DS20070278 DS20070279 DS20070280 DS20070281 DS20070282 DS20070283 DS20080001 DS20080002 DS20080003 DS20080004 DS20080005 DS20080006 DS20080007 DS20080008 DS20080009 DS20080010 DS20080011 DS20080016 DS20080017 DS20080018 DS20080019 DS20080020 DS20080021 DS20080022 DS20080023 DS20080024 DS20080025 DS20080026 DS20080027 DS20080028 DS20080029 DS20080030 DS20080031 DS20080032 DS20080033 DS20080034 DS20080035 DS20080036 DS20080037 DS20080038 DS20080039 DS20080040 DS20080041 DS20080042 DS20080043 DS20080044 DS20080045 DS20080046 DS20080047 DS20080048 DS20080049 DS20080050 DS20080051 DS20080052 DS20080053 DS20080054 DS20080055 DS20080056 DS20080057 DS20080058 DS20080059 DS20080061 DS20080062 DS20080063 DS20080064 DS20080065 DS20080066 DS20080067 DS20080068 DS20080069 DS20080070 DS20080071 DS20080072 DS20080073 DS20080074 DS20080075 DS20080076 DS20080077 DS20080078 DS20080079 DS20080080 DS20080081 DS20080082 DS20080083 DS20080084 DS20080085 DS20080086 DS20080087 DS20080088 DS20080089 DS20080090 DS20080091 DS20080092 DS20080093 DS20080094 DS20080095 DS20080096 DS20080097 DS20080098 DS20080099 DS20080100 DS20080101 DS20080102 DS20080103 DS20080104 DS20080105 DS20080106 DS20080107 DS20080108 DS20080109 DS20080110 DS20080111 DS20080112 DS20080113 DS20080114 DS20080115 DS20080116 DS20080117 DS20080118 DS20080119 DS20080120 DS20080121 DS20080122 DS20080123 DS20080124 DS20080125 DS20080126 DS20080127 DS20080128 DS20080129 DS20080130 DS20080131 DS20080132 DS20080133 DS20080134 DS20080135 DS20080136 DS20080137 DS20080138 DS20080139 DS20080140 DS20080141 DS20080142 DS20080143 DS20080144 DS20080145 DS20080146 DS20080147 DS20080148 DS20080149 DS20080150 DS20080151 DS20080152 DS20080153 DS20080154 DS20080155 DS20080156 DS20080157 DS20080158 DS20080159 DS20080160 DS20080161 DS20080162 DS20080163 DS20080164 DS20080165 DS20080166 DS20080167 DS20080168 DS20080169 DS20080170 DS20080171 DS20080172 DS20080173 DS20080174 DS20080175 DS20080176 DS20080177 DS20080178 DS20080179 DS20080180 DS20080181 DS20080182 DS20080183 DS20080184 DS20080185 DS20080186 DS20080187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Anesthesiology Devices

2

No

Worldwide Distribution-USA (nationwide) and the country of MALAYSIA.

INOmax DS (Delivery System) Model 10003 & 10007. || The INOMAX DS Delivery System delivers INOMAX (nitric oxide for inhalation) therapy gas into the inspiratory limb of the patient breathing circuit in a way that provides a constant concentration of nitric oxide (NO), as set by the user, to the patient throughout the inspired breath. It uses a specially designed injector module, which enables tracking of the ventilator waveforms and the delivery of a synchronized and proportional dose of NO. It may be used with most ventilators. The INOMAX DS provides continuous integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system.

Serial Numbers: DS20080152, DS20090218, DS20090243, DS20090271, DS20090523, DS20090598, DS20090821, DS20090925, DS20101022, DS20101076, DS20101147, DS20101374, DS20101413, DS20101420,  DS20101499, DS20101637, DS20111199, DS20120099, DS20120150, DS20120169, DS20120288, DS20120306.

Anesthesiology Devices

2

No

Nationwide Distribution including DC and VA.

INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version 3.0.0. The INOmax DS delivery system delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates.

Model Catalog: DS 20050006 (Lot serial: >10 contact manufacturer); Model Catalog: DS 20050006 (Lot serial: >10 NUMBERS CONTACT MFG)

INOMAX DS drug delivery-system