Cadd-Diplomat Pc Communications System and the Cadd- Ambassador Pump Communications System

• • Terminated Z-0718-2007 FDA Unclassified (pre-2012) ·initiated 19 Jan 2007

  The year of manufacture had been incorrectly entered as 1980 into the pumps software during the manufacture process. As a result the pump may go into an immediate 'Clock battery is Low/Service Immediately' or 'Clock Battery needs service soon' alarm message indicating that the pump requires servicing.

510(k) Number

K973917 ↗

FDA Product Code

FRN

Device Class

Class II

Regulation

21 CFR Part 880.5725

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Port-A-Cath P.A.S. Port II Implantable Venous Access Sytems

  Class II

  FDA 510(k) K961580 Active Cleared 20 Sep 1996

• Sims Silo Needle De-Access Enclosure

  Class II

  FDA 510(k) K935767 Active Cleared 15 Nov 1995

• Port-A-Cath II Trans-Arterial Percutaneous System

  Class II

  FDA 510(k) K992697 Active Cleared 18 Nov 1999

• Cadd Administration Set, Cadd 250ml Flexible Medication Reservoir, Modified Securit Shell, Security Shell Adapter

  Class II

  FDA 510(k) K990083 Active Cleared 12 Feb 1999

• Port-A-Cath Low-Profile Implantable Access Systems

  Class II

  FDA 510(k) K973862 Active Cleared 29 Dec 1997

• Cadd Administration Set

  Class II

  FDA 510(k) K991599 Active Cleared 15 Jun 1999

See all devices from Sims Deltec, Inc. →

• What is the CADD-DIPLOMAT PC and CADD-AMBASSADOR Pump Communications System used for?

  These systems are used for communication with infusion pumps, specifically designed for general hospital settings. They are substantially equivalent to Sabratek's MediVIEW™ Software Package used with their Homerun™ Model 6060 Ambulatory Infusion Pump and the current Modem used with SIMS Deltec's CADD-Prizm™ Model 6100 Ambulatory Infusion Pump.

• What is the regulatory status of these communication systems?

  The CADD-DIPLOMAT PC and CADD-AMBASSADOR Pump Communications Systems are Class II medical devices with FDA 510(k) clearance under product code FRN. They are regulated under number 880.5725 and are intended for use in general hospital settings.

• How are these communication systems supplied?

  The devices are supplied by Sims Deltec, Inc. They are designed to work with specific infusion pump models and are part of a comprehensive communication system for infusion therapy management in hospital environments.

• What models of infusion pumps are compatible with these communication systems?

  The CADD-DIPLOMAT PC and CADD-AMBASSADOR Pump Communications Systems are compatible with Sabratek's Homerun™ Model 6060 Ambulatory Infusion Pump and SIMS Deltec's CADD-Prizm™ Model 6100 Ambulatory Infusion Pump, providing seamless communication capabilities for these devices.