The Implant Files -
International Medical Devices Database
- About this investigation
- International Medical Devices Database
- Tell us your story
- Resources for patients
- Reporting partners
- Video introduction
Historias - Patients harmed by medical devices
- Europe, a device gateway to the world
- History of the industry
- The Medtronic way
- Ruptured trust and breast implants
- Heart device raises risk questions
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Modelo / Serial
All in date cartridges
- Clasificación del producto
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Clase de dispositivo
2
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¿Implante?
No
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Distribución
Worldwide distribution: USA (nationwide) and countries of: CANADA, ARGENTINA, AUSTRALIA ,AUSTRIA, BELGIUM, BRAZIL, CHILE, CHINA, CROATIA (local name: Hrvatska), CZECH REPUBLIC, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, GUATEMALA, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, MALAYSIA, MEXICO, NETHERLANDS, NORWAY, PANAMA, POLAND, PORTUGAL, PUERTO RICO, SAUDI ARABIA, SLOVENIA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, PROVINCE OF CHINA TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, and VIET NAM.
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Descripción del producto
GEM PREMIER 4000 CARTRIDGE K+ REPORTING: || GEM 4000 BG/Hct/Lytes/G/L/CO-Ox/tBili : || 75 test iQM Part Number:00027407511 || 150 test iQM Part Number: 00027415011 || 300 test iQM Part Number: 00027430011 || 450 test iQM Part Number: 00027445011 || 600 test iQM part Number: 00027360011 || The GEM Premier 4000 is a portable critical care system for use by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pC02, p02, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb, 02Hb, COHb, MetHb, HHb) parameters.
- Manufacturer
- 4 Events
Fabricante
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Dirección del fabricante
Instrumentation Laboratory Co., 180 Hartwell Road, Bedford MA 01730-2443
- Empresa matriz del fabricante (2017)
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Source
USFDA
8 dispositivos con un nombre similar
Más información acerca de la data acá
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Modelo / Serial
Lot Number: 306355 Expires: 8/31/2003
- Clasificación del producto
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Clase de dispositivo
2
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¿Implante?
No
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Distribución
CA, FL, NY, PA, TN,
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Descripción del producto
GEM Premier 3000 Pak pH, pC02, pO2, Hct Sensor and Reagent Cartridge. || Part No. 24330004 (300 Sample Size) || For In-Vitro Diagnostic Use
- Manufacturer
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Modelo / Serial
Lot Number: 306360 Expires: 8/31/2003
- Clasificación del producto
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Clase de dispositivo
2
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¿Implante?
No
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Distribución
CA, FL, NY, PA, TN,
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Descripción del producto
GEM Premier 3000 Pak Sensor pH, pC02, pO2, Hct and Reagent Cartridge. || Part No. 24345004 (450 Sample Size) || For In-Vitro Diagnostic Use
- Manufacturer
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Modelo / Serial
Software prior to Version V3.5
- Clasificación del producto
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Clase de dispositivo
2
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¿Implante?
No
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Distribución
Florida Canada
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Descripción del producto
ACL Futura Instrument Analyzer
- Manufacturer
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Modelo / Serial
Software version prior to V2.1
- Clasificación del producto
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Clase de dispositivo
2
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¿Implante?
No
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Distribución
Florida Canada
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Descripción del producto
ACL Advance Instrument Analyzer
- Manufacturer
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Modelo / Serial
Serial numbers starting with 18412
- Clasificación del producto
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Clase de dispositivo
2
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¿Implante?
No
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Distribución
Nationwide Foreign: Canada
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Descripción del producto
GEM PREMIER 3000
- Manufacturer