Devices

ACCUCHEK

  • 모델명 / 제조번호(시리얼번호)
    AccuChek Aviva Combo meter 05075645005 packaged in Accu-Chek Combo Kit mg US/English version, 05458544001 and Accu-Chek Combo Kit mg US/Spanish version, 05504686001.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution.
  • 제품 설명
    ACCU-CHEK Aviva Combo Blood Glucose Meter (as a part of the ACCU-CHEK Aviva Combo System)\ || The ACCU-CHEK Combo System is indicated for the treatment of insulin-requiring diabetes and for the quantitative measurement of glucose in fresh capillary whole blood from the finger.
  • Manufacturer
    Roche Diagnostics Operations, Inc.
  • 1 Event

제조사

Roche Diagnostics Operations, Inc.
  • 제조사 주소
    Roche Diagnostics Operations, Inc., 9115 Hague Rd, Indianapolis IN 46256-1025
  • 제조사 모회사 (2017)
    Roche Holding AG
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 87 건

데이터에 대해 더 자세히 알아보기 여기

Device Recall Roche ACCUCHEK Softclix Lancing Device
  • 모델명 / 제조번호(시리얼번호)
    Model 3144844001; lots M25C2, M25C5, M25C7, N32A5 and M32B5. Model 3583031002; lots M25C9, M25D2, M27D6, M32A8 and M32B3.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide.
  • 제품 설명
    Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche Diagnostics, Indianapolis, IN. Models 3144844001 (10 lancets) and 3583031002 (17 lancets). || The device is used to prick the finger and to obtain a drop of blood in preparation for diabetes/insulin level testing.
  • Manufacturer
    Roche Diagnostics Corp.
Device Recall Roche ACCUChek Active Meter Kit
  • 모델명 / 제조번호(시리얼번호)
    REF 03184501001; lots 116099, 116109, 116122, 116135, 116145, 116146, 116155, 116167, 116185, 116190, 116192, 116205, 116209, 116215, 116229, 116230 and 116237. Lancet Model 3144844001; lots M25C2, M25C5, M25C7, N32A5 and M32B5.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide.
  • 제품 설명
    Roche ACCU-Chek Active Meter Kit, Roche Diagnostics, Indianapolis, IN; REF 03184501001 includes the Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche Diagnostics, Indianapolis, IN. Model 3144844001 (10 lancets). || The device is used to prick the finger and to obtain a drop of blood in preparation for diabetes/insulin level testing.
  • Manufacturer
    Roche Diagnostics Corp.
Device Recall Roche ACCUChek Voicemate Meter
  • 모델명 / 제조번호(시리얼번호)
    REF 12030802001; lot 550594A. Lancet Model 3144844001; lots M25C2, M25C5, M25C7, N32A5 and M32B5.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide.
  • 제품 설명
    Roche ACCU-Chek Voicemate Meter, Roche Diagnostics, Indianapolis, IN; REF 12030802001 includes the Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche Diagnostics, Indianapolis, IN. Model 3144844001 (10 lancets). || The device is used to prick the finger and to obtain a drop of blood in preparation for diabetes/insulin level testing.
  • Manufacturer
    Roche Diagnostics Corp.
Device Recall Roche ACCUChek Aviva Meter Kit
  • 모델명 / 제조번호(시리얼번호)
    REF 04893247001; lots 122136, 122137, 122143, 122155, 122179, 122187, 122196, 122198, 122213, 122224 and 122236. Lancet Model 3144844001; lots M25C2, M25C5, M25C7, N32A5 and M32B5.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide.
  • 제품 설명
    Roche ACCU-Chek Aviva Meter Kit, Roche Diagnostics, Indianapolis, IN; REF 04893247001 includes the Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche Diagnostics, Indianapolis, IN. Model 3144844001 (10 lancets). || The device is used to prick the finger and to obtain a drop of blood in preparation for diabetes/insulin level testing.
  • Manufacturer
    Roche Diagnostics Corp.
Device Recall Roche ACCUChek Coaguchex XS Systems for Patient SelfTesting
  • 모델명 / 제조번호(시리얼번호)
    REF 03149137001; lots 116137, 116148, 116151, 116157, 116180, 116194, 116199, 116216, 116224 and 116234. REF 05177294001; lots 116142, 116158 and 116204. REF 05079241001; lots 116134, 116141, 116149, 116164, 116170, 116171, 116188, 116191, 116202, 116207, 116212, 116217, 116221, 116231 and 116236. Lancet Model 3583031002; lots M25C9, M25D2, M27D6, M32A8 and M32B3.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide.
  • 제품 설명
    Roche ACCU-CHEK Compact Plus Meter Kit, Roche Diagnostics, Indianapolis, IN; REFS 03149137001, 05177294001 and 05079241001 include the Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche Diagnostics, Indianapolis, IN. Model 3583031002 (17 lancets). || The device is used to prick the finger and to obtain a drop of blood in preparation for diabetes/insulin level testing.
  • Manufacturer
    Roche Diagnostics Corp.
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