Datascope Corporation

33 devices in the database

  • Model / Serial
    Lot number 3000033848
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the state of : CA.
  • Product Description
    Custom Tubing Pack with Bioline Coating || UDI code: 00607567208230 || Part Number: 709000058 || The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile, non-sterile, and bulk packed. Custom tubing sets that are sold sterile are not to be re-sterilized by the user. In open heart surgery the HLM Tubing Sets with Bioline Coating are used in combination with the heart-lung machine for the oxygenation of blood and removal of carbon dioxide. The main purpose of the HLM Tubing Sets with Bioline Coating is to connect the patient to the heart-lung machine and its components. The HLM Tubing Sets with Bioline Coating are therefore a component in the extracorporeal perfusion circulation system. The utilization period of the use of the tubing sets is restricted to six hours. The Bioline Coating improves the physical surface properties of products for the extracorporeal circulation system.
  • Model / Serial
    0684 00 0296 01U and 0684 00 0296 02U
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    Intra-Aortic Balloon Catheter Mega 8FR 50cc || Product Usage: || The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle.
  • Model / Serial
    0684 00 0294 01U and 0684 00 0294 02U
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    Intra-Aortic Balloon Catheter Mega 7.5FR 30cc || Product Usage: || The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle.
  • Model / Serial
    0684 00 0295 01U and 0684 00 0295 02U
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    Intra-Aortic Balloon Catheter Mega 7.5FR 40cc || Product Usage: || The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle.
  • Model / Serial
    Batch Number 3000020957, UDI Code 10607567203522
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The products were distributed to the following US states: AL, OR, and TX.
  • Product Description
    Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 15801 Neonatal Special, Part Number 701055490
28 more

5 manufacturers with a similar name

Learn more about the data here

  • Manufacturer Parent Company (2017)
  • Source
    NZMMDSA
  • Manufacturer Address
    Datascope Corporation, 15 Law Dr, Fairfield NJ 07004-0011
  • Manufacturer Parent Company (2017)
  • Source
    USFDA
  • Manufacturer Address
    Datascope Corporation, 14 Philips Pkwy, Montvale NJ 07645-1811
  • Source
    USFDA