Devices

Medrad Mark 7 Arterion Injection System

Model / Serial
Catalog numbers: ART 700 PEDL, ART 700 TABL, ART 700 OCS, which utilize Software Version SW 005.006_SH. Affected serial numbers: 20329, 20570, 101148, 20392, 20425, 20427, 30046, 100945, 100186, 21255, 30086, 20025, 101153, 101159, 20714, 100873, 20437, 100033, 100249, 20333, 100511, 101206, 100002, 100890, 101208, 20323, 20914, 20342, 10172, 10074, 20195, 20196, 20850, 20929, 101106, 30020, 30024, 30033, 20252, 10087, 20851, 100009, 100864, 100335, 10095, 20302, 20306, 100013, 20918, 100141, 20158, 100784, 20735, 20422, 101149, 20842, 20018, 101114, 100056, 100075, 20434, 21024, 20311, 20763, 10055, 20786, 20701, 20729, 20040, 100092, 20501
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution. US Nationwide, Germany, France, UK, Netherlands, Sweden, and Canada.
Product Description
Angiographic Injector. Medrad Mark 7 Arterion Injection System, which utilizes Software Version SW 005.006_SH; to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies.
Manufacturer
Bayer Healthcare
1 Event
- Recall of Medrad Mark 7 Arterion Injection System

Manufacturer

Bayer Healthcare

Manufacturer Address
Bayer Healthcare, 1 Bayer Dr, Indianola PA 15051-9702
Manufacturer Parent Company (2017)
Bayer AG
Source
USFDA

2 devices with a similar name

Learn more about the data here

Medrad Mark 7 Arterion injection system

Model / Serial
Product Description
Bayer Medical Care: Medrad Mark 7 Arterion injection system
Manufacturer
Bayer Medical Care

MEDRAD MARK 7 ARTERION INJECTION SYSTEM (CEILING MOUNT SYSTEM)

Model / Serial
Model Catalog: ART 700 OCS (Lot serial: 20422); Model Catalog: ART 700 PEDL (Lot serial: 100785); Model Catalog: ART 700 TABL (Lot serial: 20735); Model Catalog: ART 700 TABL (Lot serial: 101149)
Product Description
MEDRAD MARK 7 ARTERION INJECTION SYSTEM (CEILING MOUNT SYSTEM)
Manufacturer
BAYER MEDICAL CARE INC.

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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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