Datex - Ohmeda, Inc

Systems id: 77573841, 80158241, 910063039, 3018774100, 4103374100, 4438494100, 5134754100, 5138534100, 6029234100, 8159374100, 8595724100, 9408984100, 82406010011, 082416130011, 82416130012, 00095VAS07, 205759CL2, 216844INNOVA, 229228INNOV41V, 229434INNOV, 239436CATH1, 251435ICV5, 304255INNOVA, 304347INNOVA, 315448RM4, 315448RM5, 319338VA4100, 325670CATH, 337981INNOVA, 352333VASC, 352376SP, 352401CATH, 352401VASC, 407518SP2, 407518SP3, 407SPECIALS, 414961INN4100, 478633INOV, 508856OR41, 515263IL4100, 516562INNOVA4, 573632CRA, 573761SMA, 574535IN41, 600050VA01, 6012884100SP1, 606833INNOVA, 609652CATH3, 614293LIBERTY1, 614293LIBERTY2, 704487CR41, 706802FINN, 715369INN4100, 717763INNOVA41, 717763OR4100, 718518CVL1, 724656ANG, 727725SPEC1, 727819SPSC, 740592INNOVA, 757398INNOVA, 757736INNOVA, 803329CL41, 804320CATH2B, 804594CATH, 812279INNOVA1, 813972INTV, 816276SP1, 817255NH4100, 828696IN41, 865541CCL5, 865693CCL3, 901726SP2, 903CSM4100, 904276SP, 906485ANGIO, 918307SHIN4, 941483INNOVA41, 956632INN4100, A5630803, B5801711, BE5005VA01, BY4020VA01, RU1018VA03, SA1188VA03, SLIN4100, YV0003.

Radiology Devices

2

No

Worldwide Distribution - AL, AZ, CA, FL,, GA, HI, IA,IL, IN, KY, LA,MA, MD, MI, MO, MS, NC, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WI, and WV, Puerto Rico. OUS to include: Australia, Byelarus, China, Denmark, France, Germany, Greece, Honduras, Iran, Iraq, Italy, Japan, Latvia, Lebanon, Mexico, Poland, Russia, Saudi Arabia, Turkey, United Kingdom, and Venezuela.

GE Healthcare Innova 4100 Digital Fluoroscopic Imaging (Cardiovascular Imaging System

Systems Id: 8613100, 0910163013, 4103323100, 4103623100, 5034353100, 7083333100, 7278253100, 8019643100, 82416040010, 082416040016, 082416040017, 082416050002, 082416070004, 082416100008, 82416120005, 082416120006, 082416130013, 0002581738X, 06074VAS01, 201541LAB2, 214324INNOVA2, 24516572980IN, 309691P3100, 310423INNOVA1, 313593IC1, 313593IC2, 314525SACL2, 314768SMCL3, 318448INNOVA2, 318449INNOVA2, 409899LAB3, 413447CATH, 413540IN1, 417269SCLD, 502587LAB4, 518525LAB1, 540953INNOVA, 561266IN31, 563421CATHLAB8, 573815BCR1, 600130VA01, 601553CL3, 602239LAB4, 602239LAB6, 602266LAB2, 603778ECL1, 608524NOVA, 615338CV2, 615769SKYCV2, 619340VA8, 619482INNOVA1, 619541INNOVA31, 619552INNOVA1, 702616INNOVA, 7028803100A, 713794LAB7, 713794LAB9, 714966INNOVA, 718283INNOVA3, 724773C1, 731422CV1, 732294INOV, 765453INNOVA1, 770991CL3, 773792CL3100, 773NORWG3100, 803329CL31, 808547QCV2A, 812238LIB1, 812283IN31, 812482INNOVA, 815599FHN3100, 817433HSW3100, 83INNOVA1188379, 850678IN3100, 904202CATH3, 908522LAB1, 928779INNOVA1, 936266CL1, 956389INN31, 956698INN31, 956994INN1, 956994INN2, 973971LAB3, A5108239, A5203215, BPINNOVA2, BPINNOVA3R, DK1066VA01, FHORLCL1, H1420VAS04, HC1536XR04, IQ1083VA01, IR1747VA01, LB1160XR07, LV4012VA01, M2848425, M2970614, PL1622VA01, RU1156VA01, RU1482VA02, RU1550VA01, RU2457VA01, TT-2586581-CO, YV0022, YV0026, YV0036.

Radiology Devices

2

No

Worldwide Distribution - AL, AZ, CA, FL,, GA, HI, IA,IL, IN, KY, LA,MA, MD, MI, MO, MS, NC, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WI, and WV, Puerto Rico. OUS to include: Australia, Byelarus, China, Denmark, France, Germany, Greece, Honduras, Iran, Iraq, Italy, Japan, Latvia, Lebanon, Mexico, Poland, Russia, Saudi Arabia, Turkey, United Kingdom, and Venezuela.

GE Healthcare Innova 3100 Digital Fluoroscopic Imaging (Cardiovascular Imaging System)

All serial numbers

Anesthesiology Devices

2

No

Worldwide Distribution --- USA including state of TX and countries of Austria, Bangladesh, Belgium, Costa Rica, Denmark, Finland, France, Germany, India, Italy, Mexico, Saudi Arabia, South Africa, Sweden, Switzerland, United Kingdom, United Arab Emirates.

GE Datex-Ohmeda Neonatal Enhancement for the Engstrom Carestation, Model # 1505-3272-00, GE Healthcare P.O. Box 7550, Madison, WI 53707-7550, USA || Intended to provide mechanical ventilation for adults and pediatrics weighing 5kg and above having degrees of pulmonary impairment varying from minor to severe.

EZchange Manifold with part number 1407-7021-000,  1407-7027-000, M1053007, M1053008.

Anesthesiology Devices

1

No

Worldwide, including USA, Australia, Belgium, Brazil, Canada, Chile, China, Denmark, Egypt, Estonia, Finland, France, Germany, India, Ireland, Italy, Jordan, Republic of Korea, Kuwait, Mexico, Netherlands, New Zealand, Norway, Peru, Poland, Qatar, Singapore, Slovak Republic, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom, and Venezuela.

GE Disposable Multi Absorber Canister used with EZchange Module for the Aisys, Avance, Aespire Anesthesia systems. The EZchange Module is an optional accessory for these anesthesia systems.

serial number: 00000007C20046, 00000088514VE5, 00000453906BU0, 00000453949BU0, 00000464077BU7, 00000464473BU8, 00000477785BU0, 00000477790BU0, 00000477801BU5, 00000477819BU7, 00000477822BU1, 00000477831BU2, 00000477835BU3, 00000477837BU9, 00000477841BU1, 00000479528BU2, 00000489698BU1, 00000489699BU9, 00000489768BU2, 00000496743BU6, 00000497530BU6, 00000498660BU0, 00000499684BU9, 00000499708BU6, 00000505091BU9, 00000509178BU0, 00000509203BU6, 00000509244BU0, 00000509248BU1, 00000509254BU9, 00000511620BU7, 00000511652BU0, 00000511702BU3, 00000512694BU1, 00000512706BU3, 00000512710BU5, 00000512721BU2, 00000512824BU4, 00000512830BU1, 00000512832BU7, 00000512833BU5, 00000512863BU2, 00000512865BU7, 00000512881BU4, 00000512886BU3, 00000512893BU9, 00000512896BU2, 00000512908BU5, 00000513090BU1, 00000513142BU0, 00000513174BU3, 00000513198BU2, 00000513200BU6, 00000513203BU0, 00000513218BU8, 00000513227BU9, 00000513242BU8, 00000513243BU6, 00000513540BU5, 00000513550BU4, 00000513559BU5, 00000519098BU8, 00000526307BU4, 00000526310BU8, 00000526349BU6, 00000526385BU0, 00000526537BU6, 00000526676BU2, 00000526678BU8, 00000528507BU7, 00000528634BU9, 00000529470BU7, 00000529682BU7, 00000530250BU0, 00000544202BU5, 00000545958BU1, 00002UA63008FC, 000782415-0004. systems id: 574294IN41.

Radiology Devices

2

No

within US: AL, AR, AZ, CA,CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and Puerto Rico. OUS to include: Algeria, Australia, Belgium, Brazil, Canada, China, Columbia, Denmark, Finland, France, Germany, Greece, Hungary, India, Indonesia, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Malaysia, Mexico, New Zealand, Norway, Russia, Saudi Arabia, Singapore, Spain, Switzerland, Syria, Taiwan, Turkey, and United Kingdom

GE Healthcare Innova 4100 IQ Digital Fluoroscopic Imaging System (Vascular Angiography system). The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy of cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications.