International Technidyne Corp.

AVOXimeter 1000: K922075 AVOX1000, AVOX1000E-110, AVOX1000INT  AVOXimeter 4000: K951485 AVOX4000, AVOX4000D

Anesthesiology Devices

2

No

Worldwide Distribution - USA including TX, KS, OH, OR, FL, GA, NY, MA, and DC and the countries of Taiwan and Thailand

AVOXimeter 1000, AVOXimeter 4000 || 1000- portable bedside whole blood oximeter that directly measures oxyhemoglobin fraction, the total hemoglobin concentration, and oxygen content. It has enhanced software that optimizes its use int he cardiac catheterization laboratory through calculations of physiologic equations. 4000-a portable bedside whole blood CO-oximeter that directly measures total hemoglobin concentration and the relative concentrations of oxyhemoglobin carboxyhemoglobin concentration methemoglobin. In addition, oxygen content oxygen capacity and oxygen saturation indices are calculated.

Catalogue/Code J201  Lot Number:  FOJPT059, GOJPT067,  GOJPT068,  GOJPT069,  GOJPT070,  GOJPT072,  GOJPT073,  GOJPT074,  GOJPT075,  HOJPT076,  HOJPT077,  HOJPT078,  HOJPT079,  HOJPT080,  HOJPT081,  HOJPT082,  HOJPT083,  JOJPT084,  JOJPT085,  JOJPT086,  JOJPT087,  JOJPT088,  JOJPT090,  KOJPT091,  KOJPT092,  KOJPT093,  MOJPT094,  MOJPT095,  MOJPT096,  MOJPT097,  MOJPT098,  MOJPT099,  A1JPT001,  A1JPT002  A1JPT003  A1JPT005  A1JPT007  A1JPT008,  A1JPT009,  A1JPT010,  A1JPT011,  A1JPT012,  A1JPT013,  A1JPT014,  A1JPT015,  A1JPT016,  A1JPT017,  A1JPT018,  A1JPT019,  A1JPT021,  A1JPT023,  A1JPT024,  A1JPT025,  B1JPT032,  B1JPT033,  C1JPT035,  C1JPT038,  C1JPT041,  and C1JPT045.

Hematology and Pathology Devices

2

No

Worldwide Distribution: (USA) Nationwide Distribution including the countries of; Austria, Australia, Canada, Switzerland, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Hong Kong, Ireland, Israel, India, Italy, Korea, Liechtenstien, Libya, Netherlands, Norway, Oman,Portugal, Qatar, Saudi Arabia, Sweden, Turkey, Taiwan, and South Africa.

Hemochron JR. Microcoagulation Systems Prothrombin Time (PT). || International Ethidine Corp (ITC)-Nexus Dx. || A unitized mlcrocoagulation test intended for use in performing one-stage prothrombin time.

ID #: 6260030000.  Lot Numbers:  A1ILJPT001, H0ILJPT005, and K0ILJPT006.

Hematology and Pathology Devices

2

No

Worldwide Distribution: (USA) Nationwide Distribution including the countries of; Austria, Australia, Canada, Switzerland, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Hong Kong, Ireland, Israel, India, Italy, Korea, Liechtenstien, Libya, Netherlands, Norway, Oman,Portugal, Qatar, Saudi Arabia, Sweden, Turkey, Taiwan, and South Africa.

IL GEM PCL/PCL Plus - Gem Test PT Cartridge || ITC-Nexus Dx || A unitized mlcrocoagulation test intended for use in performing one-stage prothrombin time.

Pro3-25    A2K3C001 1/31/2013 A2K3C002 1/31/2013 A2P3C003 1/31/2013 A2P3C004 1/31/2013 A2K3C005 1/31/2013 A2K3C006 1/31/2013 A2K3C007 1/31/2013 A2K3C008 1/31/2013 A2K3C009 1/31/2013 A2K3C011 1/31/2013 A2K3C013 1/31/2013 A2K3C015 1/31/2013 A2K3C016 1/31/2013 A2K3C017 1/31/2013 A2K3C018 1/31/2013 A2K3C019 1/31/2013 A2K3C020 1/31/2013 A2K3C021 1/31/2013 A2K3C022 1/31/2013 A2K3C023 1/31/2013 A2K3C0241/31/2013 A2K3C025 1/31/2013 A2K3C026 1/31/2013 A2K3C027 1/31/2013 B2K3C028 2/28/2013  B2K3C030 2/28/2013 B2K3C031 2/28/2013 B2K3C032 2/28/2013 B2K3C033 2/28/2013 B2K3C034 2/28/2013 B2K3C035 2/28/2013 B2K3C036 2/28/2013 B2K3C037 2/28/2013 B2K3C038 2/28/2013 B2K3C039 2/28/2013 B2K3C040 2/28/2013 B2K3C041 2/28/2013 B2K3C042 2/28/2013 B2K3C043 2/28/2013 B2K3C044 2/28/2013 B2K3C045 2/28/2013 B2K3C046 2/28/2013 C2K3C048 3/31/2013 C2K3C049 3/31/2013 C2K3C050 3/31/2013 C2K3C051 3/31/2013 C2K3C052 3/31/2013 C2K3C053 3/31/2013 C2K3C054 3/31/2013 C2K3C055 3/31/2013 C2K3C056 3/31/2013 C2K3C058 3/31/2013 C2K3C059 3/31/2013 C2K3C061 3/31/2013 D2K3C078 4/30/2013 M1K3C474 12/31/2012 M1K3C475 12/31/2012 M1K3C476 12/31/2012 M1K3C477 12/31/2012 M1P3C478 12/31/2012 M1P3C479 12/31/2012 M1P3C480 12/31/2012 M1P3C481 12/31/2012 M1P3C482 12/31/2012   PRO3-4  A2K3H015 1/31/2013 B2K3H029 2/28/2013 B2K3H033 2/28/2013 B2K3H047 2/28/2013 C2K3H049 3/31/2013 C2K3H055 3/31/2013 C2K3H057 3/31/2013  PRO3-50  B2P3C029 2/28/2013 B2P3C030 2/28/2013 B2P3C033 2/28/2013 C2P3C057 3/31/2013

Hematology and Pathology Devices

2

No

Worldwide Distribution - USA (nationwide) and Internationally to Bermuda, Canada, Chile, Denmark, Germany, Italy, Latvia, Lithuania, Malaysia, Philippines, South Africa, Spain, Switzerland, Taiwan, and United Arab Emirates.

Pro Time Microcoagulation System/ Pro Time 3 Cuvette, Pro3-4, Pro3-25, and Pro3-50. || International Technidyne Corporation. || The Pro Time Microcoagulation System is a portable battery operated instrument with a disposable cuvette for quantitative determination of prothrombin time from fingerstick whole blood or anticoagulant free venous whole blood.