Datascope Corporation

Part Number 0998-00-0191-04

Cardiovascular Devices

2

No

Nationwide

Datascope, Panorama Patient Monitoring Network; Panorma Telepack 608;Software Versions 8.1.X, 8.3, 8.3.1, 8.4.1, and 8.5.X, Part Number: 0998-00-0191-04, Datascope Corp., Mahwah, NJ

Product number 0998-00-0446-XX and 0998-00-0479-XX. SN# S8119767B8 S8119768B8 S8119769B8 S8119771B8 S8119773B8 S8119774B8 S8119775B8 S8119778B8 S8119780B8 S8119781B8 S8119782B8 S8119764B8 S8119766B8 S8119770B8 S8119772B8 S8119776B8 S8119779B8

Cardiovascular Devices

2

No

Class 2 - Worldwide distribution -- US and Distribution to Australia, Belarus, Belgium, Canada, Egypt, England, Germany, Hong Kong, India, Iran, Israel, Japan, Kuwait, Latvia, Lebanon, Serbia, Singapore, Spain, Switzerland, Turkey, Venezuela.

System 98XT/98 Intra-Aortic Balloon Pump || This product was only distributed in India and Hong Kong/China.

Product number 0998-00-3013-XX SN# SI126162D8 SI120003C8 SI122070C8 SI147171J8 SI124922D8 SI118561B8 SI121095C8 SI121099C8 SI122072C8 SI118566B8 SI119984C8 SI119986C8 SI119994C8 SI119997C8 SI120015C8 SI120021C8 SI120022C8 SI121087C8 SI119989C8 SI118559B8 SI119999C8 SI120000C8 SI120001C8 SI120005C8 SI120009C8 SI120017C8 SI121091C8 SI121100C8 SI124933D8 SI121090C8 SI120008C8 SI124911D8 SI124918D8 SI120004C8 SI120018C8 SI120020C8 SI121085C8 SI121097C8 SI121098C8 SI121103C8 SI121104C8 SI121107C8 SI121117C8 SI122075C8 SI120023C8 SI120019C8 SI121115C8 SI121119C8 SI122073C8 SI120006C8 SI120013C8 SI120014C8 SI121081C8 SI121082C8 SI121083C8 SI121094C8 SI121102C8. International: SI118567B8 SI118558B8 SI135828G8 SI118560B8 SI118565B8 SI119992C8 SI119987C8 SI119988C8 SI124910D8 SI135278G8 SI118562B8 SI119995C8 SI119985C8 SI118563B8 SI121084C8 S8119777B8 SI124923D8 SI121089C8 SI124939D8 SI124937D8 SI118564B8 SI124915D8 SI119991C8 SI119998C8 SI121096C8 SI158367D9  SI124920D8.

Cardiovascular Devices

2

No

Class 2 - Worldwide distribution -- US and Distribution to Australia, Belarus, Belgium, Canada, Egypt, England, Germany, Hong Kong, India, Iran, Israel, Japan, Kuwait, Latvia, Lebanon, Serbia, Singapore, Spain, Switzerland, Turkey, Venezuela.

CS300 Intra-Aortic Balloon Pump

Product number 0998-00-3023-XX: SA122365C8 SA122373C8. International: SA122359C8 SA122375C8 SA122358C8 SA122360C8 SA122363C8 SA122362C8 SA122361C8 SA122368C8 SA147699K8 SA122366C8 SA122370C8 SA119292B8 SA122371C8 SA122364C8 SA122367C8 SA122369C8 SA122372C8.

Cardiovascular Devices

2

No

Class 2 - Worldwide distribution -- US and Distribution to Australia, Belarus, Belgium, Canada, Egypt, England, Germany, Hong Kong, India, Iran, Israel, Japan, Kuwait, Latvia, Lebanon, Serbia, Singapore, Spain, Switzerland, Turkey, Venezuela.

CS100 Intra-Aortic Balloon Pump.

Part Number: 0012-00-1589-03 Rev. C, RAM 0827.

Cardiovascular Devices

2

No

Nationwide Distribution -- states of IL and FL.

Low-Level Output Cable. || The device is used to allow the information displayed on the Intra-aortic balloon pump (IABP) to be displayed on a separate patient monitor.