International Medical Devices Database

Manufacturer Address
Acist Medical Systems, 7905 Fuller Rd, Eden Prairie MN 55344-2137
Manufacturer Parent Company (2017)
Bracco Spa
Source
USFDA
2 Events
- Recall of Device Recall ACIST
- Recall of Device Recall ACIST Medical Systems Automated Manifold Kits

2 devices in the database

Device Recall ACIST

Model / Serial
23884007, 23884008, 23884009
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution including the states of AL, AK, AZ, AR, CA, CO, CT, DC, GA, HI, ID, IL, IN, IA, KS, KY, MD,MI, MN, MS, MO, NV, NH, NJ, NM, NY,NC, OR, OK, OH, PA, TN, TX, VA and WA.
Product Description
ACIST Medical Systems Inc. || The ACIST Angiographic Injection System is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures.

Device Recall ACIST Medical Systems Automated Manifold Kits

Model / Serial
Lot Number 08915J 09015T 09115H 09315D 09615N 09615U 09715X 09815F 10115D 10215G 10415D 10415W 10415Y 10515P 11015L 11115K 11215U 11315M 11715J 11815G 11915D 12415J 12615P 13115M 13415W 13815G 13915T 14015P 14115M 14615D 14615M 15415G 15715D 16115H 16315L 16515E 16615Z 16815J 16915N 17115F 17615U 17815F 18215J 18415D 18515N 18715U 18815K 18915P 19015N 19115H 19315D 19415P 19515X 19715G 19815M 19915D 20115M 20315E 20715D 20815M 20915X 21115W 21815J 21815U 22015D 23715D 23815D 23815P 24415P 24615U 25015D 25515D 26415N 26715F 26815J 26815K 27115L 27215U 27315Z 27415H 27515D 29115D 29915E 29915F 30015E 30015F 32115M 32715G 32715V 32815M
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US including all states except DE, MT, RI, UT, & VT and Internationally to Belgium, France, Germany, Iceland, Ireland, Luxembourg, Netherlands, Reunion, United Kingdom, Australia, Austria, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Estonia, Greece, Hong Kong, Hungary, Islamic Republic of Iran, Israel, Italy, Japan, Republic of Korea, Kuwait, Latvia, Lithuania, Mexico, New Caledonia, Norway, Panama, Poland, Portugal, Saudi Arabia, Serbia, Slovenia, Bosnia and Herzegovina, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, and Venezuela.
Product Description
ACIST Medical Systems, BT2000 Automated Manifold Kit (SKU 014613) and CPT2000 (SKU 014623) Automated Manifold Kits, Sterile R, Rx Only, Made in Mexico. || The manifold body is identical in the BT2000 and CPT2000 kits. The BT2000 and CPT2000 kits facilitate connection to, and delivery of, either contrast or saline into the patient via a coronary catheter (not provided by ACIST). || To be used for the controlled infusion of radiopaque contrast media for angiographic procedures

13 manufacturers with a similar name

Learn more about the data here

Acist Medical Systems, Inc.

Manufacturer Parent Company (2017)
Bracco Spa
Source
NIDFSINVIMA

ACIST MEDICAL SYSTEMS

Manufacturer Parent Company (2017)
Bracco Spa
Source
MSHM

Acist Medical Systems

Manufacturer Address
Acist Medical Systems, 7450 Flying Cloud Dr., Suite 150, Eden Prairie MN 55344
Source
USFDA

Acist Medical Systems

Manufacturer Address
Acist Medical Systems, 7450 Flying Cloud Dr Ste 150, Eden Prairie MN 55344-3720
Source
USFDA

ACIST Medical Systems

Manufacturer Parent Company (2017)
Bracco Spa
Source
ALIMSA

8 more

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Disclaimer

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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