ECG Cable

  • Modèle / numéro de série
    Lot Numbers: P09100310 P09100406 P09100428
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Dominica, Ecuador, Colombia, Honduras, Peru, Mexico, El Salvador, Guatemala, Venezuela, Uruguay, Chile, Panama, Nicaragua, Ecuador, Australia, Philippines, Malaysia, Indonesia, Chinese Taipei, & Spain
  • Description du dispositif
    ECG Cable Part Number: 01.57.471017 for use with the SE-1 series, SE-3 series and SE-601 series Smart Electrocardiograph || ECG cable is an accessory of the following machines: SE-1 series, SE-3 series and SE-601 series electrocardiograph (ECG). The EDAN ECG is a diagnostic and prescription device only intended to be used in hospitals or healthcare facilities by qualified doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help medical professionals to analyze and diagnose heart disease. However, the interpreted ECG with measurements and interpretive statements is offered to clinicians on an advisory basis only. ECG cable is packed in plastic bag, as an accessory putting together with ECG machine in the package box.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Edan Instruments, Inc., 7/F, Yuehai Office Bldg., 1128 Nanyou Road, Nanshan, Shenzhen Guangdong China
  • Société-mère du fabricant (2017)
  • Source
    USFDA

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  • Modèle / numéro de série
  • Description du dispositif
    md
  • Manufacturer
  • Modèle / numéro de série
    12-lead ECG Cable with Limb Lead Attachment Part Numbers: 3302822-000-AHA; 3302822-002-AHA; 3302822-001-IEC; 3302822-003-IEC.  Precordial Lead Attachment Part Numbers: 3302823-000-AHA and 3302823-001-IEC.  No Serial numbers for 12-Lead ECG Cable.
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution--USA (nationwide) including Puerto Rico and countries of Australia, Brazil, Chile, Germany, Hong Kong, Mexico, The Netherlands, and New Caledonia.
  • Description du dispositif
    12-lead ECG Cable Assembly contains the following cable and attachments: || Main Cable with Limb Leads: The main cable includes the proximal connector which attaches to the monitor and four incorporated limb lead wires that terminate with ECG electrode snaps. All signals travel through this cable for cardiac monitoring and for 12-lead ECGs. || Precordial Lead Attachment: The precordial lead attachment includes the precordial connector which attaches to the main cable with six precordial leads (also terminated with ECG electrode snaps). || This attachment is used when a 12-lead ECG is needed. The main cable includes a cover over the connector for the precordial lead attachment to protect it from contaminants if the precordial lead attachment is not || connected. || This 12-lead ECG Cable Assembly is designed for use in the Pre-hospital and hospital environment. The 12-lead ECG cables are currently available for the LIFEPAK 12 Defibrillator/Monitor and LIFEPAK 15 Monitor/Defibrillator. The 12-lead electrocardiogram is used to identify, diagnose and treat patients with cardiac disorders and is useful in the early detection and prompt treatment of patients with acute ST elevation myocardial infarction (STEMI). Documentation of transient or intermittent arrhythmias and other electrophysiologic events that occur in the prehospital setting can assist in diagnosis and treatment decisions in the Emergency Department.
  • Manufacturer
  • Modèle / numéro de série
    012-0123-01 | 31942, 34956, 35209, 35296, 35747, 36239, 36555
  • Description du dispositif
    Cable/lead, electrocardiograph
  • Manufacturer
  • Modèle / numéro de série
    Model Catalog: H787471431 (Lot serial: MBVT250D)
  • Description du dispositif
    CELERITY-ECG CABLE ACCESSORY PACK
  • Manufacturer
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