BEUDAMED
    7 results · 20ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Classification: Class Iii ×

    The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical results. It is a specially designed data program application (software), which is supplied for installation in existing mainframe or decentralized computers or a computer network. This software system will not be the software directly used to run, steer, or control any specific laboratory analyzer or equipment. It is intended for use in laboratory facilities, including a central laboratory or in a multiple laboratory environment servicing satellite laboratories, reference laboratories, clinics, etc. Centricity Laboratory System is not intended for direct patient contact. The Centricity Laboratory System product is designed to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. It integrates with other Hospital Information Systems (HIS) through HL7 interface by order entering and also report processing. The Centricity Laboratory System is intended to interface with various lab results. Centricity Laboratory System is intended to be used by laboratory technologists, technicians, analyst and other trained/site authorized system users

    FDA Enforcement
    Class III ·Terminated·GE Healthcare It·February 5, 2014

    Integrated ECG cable with 3-lead leadwires labeled as the following: 1. ECG TRUNK CABLE, 3-LD W/ INTEGRATED GRABBER LEAD WIRE, AHA, 3.6 M/12 FT; 2. ECG TRUNK CABLE, 3-LD W/ INTEGRATED GRABBER LEAD WIRE, IEC, 3.6 M/12 FT Product Usage: The reusable ECG trunk cable enables ECG monitoring with GE monitoring equipment requiring rectangular 11-pin connector cable. These accessories are indicated for use by qualified medical personnel only.

    FDA Enforcement
    Class III ·Terminated·GE Healthcare, LLC·April 3, 2019

    Leadwire sets with snap ends: REF/Catalog Number Description 2106381-001 ECG Leadwire set, 5-lead, snap, AHA, 74 cm/ 29 in 2106381-002 ECG Leadwire set, 5-lead, snap, AHA, 130 cm/ 51 in 2106381-003 ECG Leadwire set, 5-lead, snap, IEC, 74 cm/ 29 in 2106381-004 ECG Leadwire set, 5-lead, snap, IEC, 130 cm/ 51 in 2106381-005 ECG Leadwire set, 5-lead, snap, AHA, mix 74 cm/ 29 in, 130 cm/ 51 in 2106383-001 ECG Leadwire set, 5-lead, grouped, snap, AHA, 74 cm/ 29 in 2106383-002 ECG Leadwire set, 5-lead, grouped, snap, AHA, 130 cm/ 51 in 2106383-003 ECG Leadwire set, 5-lead, grouped, snap, IEC, 74 cm/ 29 in 2106383-004 ECG Leadwire set, 5-lead, grouped, snap, IEC, 130 cm/ 51 in 2106383-005 ECG Leadwire set, 5-lead, grouped, snap, AHA, mix 74 cm/ 29 in, 130 cm/ 51 in 2106383-006 ECG Leadwire set, 5-lead, grouped, snap, IEC, mix 74 cm/ 29 in, 130 cm/ 51 in 2106385-001 ECG Leadwire set, 3-lead, snap, AHA, 74 cm/ 29 in 2106385-002 ECG LEADWIRE SET, 3-LD GROUPED, SNAP, AHA, 130 CM/ 51 IN 2106385-003 ECG LEADWIRE SET, 3-LD GROUPED, SNAP, IEC, 74 CM/ 29 IN 2106385-004 ECG LEADWIRE SET, 3-LD GROUPED, SNAP, IEC, 130 CM/ 51 IN 2106394-003 ECG Leadwire set, 5-lead V2-6, snap, AHA, 74 cm/ 29 in 2106395-001 ECG Leadwire set, 6-lead, grouped, snap, AHA, 74 cm/ 29 in 2106396-001 ECG Leadwire set, 6-lead, grouped, snap, IEC, 74 cm/ 29 in 2106396-002 ECG Leadwire set, 6-lead, grouped, snap, IEC, 130 cm/ 51 in The reusable ECG leadwire sets enable ECG monitoring with GE equipment requiring rectangular 11-pin ECG trunk cable. Use leadwire sets with ECG trunk cable or telemetry transmitter.

    FDA Enforcement
    Class III ·Terminated·GE Healthcare, LLC·July 3, 2019

    Replacement leadwires with grabber ends: REF/Catalog Number Description 2106388-005 Replacement ECG Leadwire, grabber, BRN V, AHA, 74 cm/ 29 in 2106388-101 Replacement ECG Leadwire, grabber, LL , AHA, 130 cm/ 51 in 2106388-103 Replacement ECG Leadwire, grabber, GRN RL, AHA, 130 cm/ 2106388-107 Replacement ECG Leadwire, grabber, BLK N, IEC, 130 cm/ 51 in 2106392-004 Replacement ECG Leadwire, grabber, ORG V, AHA, 74 cm/ 29 in The reusable ECG leadwire sets enable ECG monitoring with GE equipment requiring rectangular 11-pin ECG trunk cable. Use leadwire sets with ECG trunk cable or telemetry transmitter.

    FDA Enforcement
    Class III ·Terminated·GE Healthcare, LLC·July 3, 2019

    ECG Trunk Cables: REF/Catalog Number Description 2106305-001 ECG Trunk Cable, 3/5-lead, AHA, 3.6 m/12 ft. 2106305-002 ECG Trunk Cable, 3/5-lead, AHA, 1.2 m/4 ft. 2106305-003 ECG Trunk Cable, 3/5-lead, IEC, 3.6 m/12 ft. 2106305-004 ECG Trunk Cable, 3/5-lead, IEC, 1.2 m/4 ft. 2106306-001 ECG Trunk Cable, Neonatal, DIN 3-lead, AHA, 3.6 m/12 ft. 2106306-002 ECG Trunk Cable, Neonatal, DIN 3-lead, AHA, 1.2 m/4 ft. 2106306-003 ECG Trunk Cable, Neonatal, DIN 3-lead, IEC, 3.6 m/12 ft. 2106306-004 ECG Trunk Cable, Neonatal, DIN 3-lead, IEC, 1.2 m/4 ft. 2106307-001 ECG Trunk Cable, 6-lead, AHA, 3.6 m/12 ft. 2106307-002 ECG Trunk Cable, 6-lead, AHA, 1.2 m/4 ft. 2106307-003 ECG Trunk Cable, 6-lead, IEC, 3.6 m/12 ft. 2106307-004 ECG Trunk Cable, 6-lead, IEC, 1.2 m/4 ft. 2106308-001 ECG Trunk Cable, 12-lead, AHA, 3.6 m/12 ft. 2106308-002 ECG Trunk Cable, 12-lead, AHA, 1.2 m/4 ft. 2106308-003 ECG Trunk Cable, 12-lead, IEC, 3.6 m/12 ft. 2106308-004 ECG Trunk Cable, 12-lead, IEC, 1.2 m/4 ft. 2106310-001 ECG Trunk Cable, 3/5-lead w/ESU filter, AHA, 3.6 m/12 ft. 2106310-002 ECG Trunk Cable, 3/5-lead w/ESU filter, IEC, 3.6 m/12 ft. 2106311-001 ECG Trunk Cable, 3/5-lead, AHA, 6 m/20 ft. 2106311-002 ECG Trunk Cable, 3/5-lead, IEC, 6 m/20 ft. The reusable ECG trunk cable enables ECG monitoring with GE monitoring equipment requiring rectangular 11-pin connector cable.

    FDA Enforcement
    Class III ·Terminated·GE Healthcare, LLC·July 3, 2019

    ECG leadwire sets: REF/Catalog Number Description 2106389-001 ECG Leadwire set, 5-lead, grouped, grabber, AHA, 74 cm/ 29 in 2106389-002 ECG Leadwire set, 5-lead, grouped, grabber, AHA, 130 cm/ 51 in 2106389-003 ECG Leadwire set, 5-lead, grouped, grabber, IEC, 74 cm/ 29 in 2106389-004 ECG Leadwire set, 5-lead, grouped, grabber, IEC, 130 cm/ 51 in 2106389-005 ECG Leadwire set, 5-lead, grouped, grabber, AHA, mix 74 cm/ 29 in, 130 cm/ 51 in 2106389-006 ECG Leadwire set, 5-lead, grouped, grabber, IEC, mix 74 cm/ 29 in, 130 cm/ 51 in 2106390-001 ECG Leadwire set, 3-lead, grabber, AHA, 74 cm/ 29 in 2106390-002 ECG Leadwire set, 3-lead, grabber, AHA, 130 cm/ 51 in 2106390-003 ECG Leadwire set, 3-lead, grabber, IEC, 74 cm/ 29 in 2106390-004 ECG Leadwire set, 3-lead, grabber, IEC, 130 cm/ 51 in 2106391-001 ECG Leadwire set, 5-lead, grabber, AHA, 74 cm/ 29 in 2106391-002 ECG Leadwire set, 5-lead, grabber, AHA, 130 cm/ 51 in 2106391-003 ECG Leadwire set, 5-lead, grabber, IEC, 74 cm/ 29 in 2106391-004 ECG Leadwire set, 5-lead, grabber, IEC, 130 cm/ 51 in 2106391-005 ECG Leadwire set, 5-lead, grabber, AHA, mix 74 cm/ 29 in, 130 cm/ 51 in 2106391-006 ECG Leadwire set, 5-lead, grabber, IEC, mix 74 cm/ 29 in, 130 cm/ 51 in 2106393-001 ECG Leadwire set, 5-lead V2-6, grabber, AHA, 130 cm/ 51 in 2106393-002 ECG Leadwire set, 5-lead C2-6, grabber, IEC, 130 cm/ 51 in 2106393-003 ECG Leadwire set, 5-lead V2-6, grabber, AHA, 74 cm/ 29 in 2106393-004 ECG Leadwire set, 5-lead C2-6, grabber, IEC, 74 cm/ 29 in 2106397-001 ECG Leadwire set, 6-lead, grouped, grabber, AHA, 74 cm/ 29 in 2106397-002 ECG Leadwire set, 6-lead, grouped, grabber, AHA, 130 cm/ 51 in 2106397-003 ECG Leadwire set, 6-lead, grouped, grabber, AHA, mix 74 cm/ 29 in, 130 cm/ 51 in 2106398-001 ECG Leadwire set, 6-lead, grouped, grabber, IEC, 74 cm/ 29 in 2106398-002 ECG Leadwire set, 6-lead, grouped, grabber, IEC, 130 cm/ 51 in The reusable ECG leadwire sets enable ECG monitoring with GE equipment requiring rectangular 11-pin ECG trunk cable. Use leadwire sets with ECG trunk cable or telemetry transmitter.

    FDA Enforcement
    Class III ·Terminated·GE Healthcare, LLC·July 3, 2019

    Replacement ECG leadwires with snap ends REF/Catalog Number Description 2106386-101 Replacement ECG Leadwire, snap, LL, AHA, 130 cm/ 51 in The reusable ECG leadwire sets enable ECG monitoring with GE equipment requiring rectangular 11-pin ECG trunk cable. Use leadwire sets with ECG trunk cable or telemetry transmitter.

    FDA Enforcement
    Class III ·Terminated·GE Healthcare, LLC·July 3, 2019