Devices

Device Recall AVOXimeter 1000, AVOXimeter 4000

Model / Serial
AVOXimeter 1000: K922075 AVOX1000, AVOX1000E-110, AVOX1000INT AVOXimeter 4000: K951485 AVOX4000, AVOX4000D
Product Classification
Anesthesiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA including TX, KS, OH, OR, FL, GA, NY, MA, and DC and the countries of Taiwan and Thailand
Product Description
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.
Manufacturer
International Technidyne Corp.
1 Event
- Recall of Device Recall AVOXimeter 1000, AVOXimeter 4000

Manufacturer

International Technidyne Corp.

Manufacturer Address
International Technidyne Corp., 68 Olsen Ave, Edison NJ 08820-2419
Manufacturer Parent Company (2017)
Werfenlife Sa.
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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