Arkon Anesthesia Delivery System

  • 모델명 / 제조번호(시리얼번호)
    *********the serial numbers and part numbers of units distributed in the US *********  Absorber Adapter Assembly Service Kit part number: 050-9045-00.  Devices serial numbers: ARKN-000395, ARKN-000396, ARKN-000397, ARKN-000398, ARKN-000399, ARKN-000400, ARKN-000401, ARKN-000402, ARKN-000403, ARKN-000404, ARKN-000405, ARKN-000406, ARKN-000407, ARKN-000408, ARKN-000409, ARKN-000410, ARKN-000411, ARKN-000412, and ARKN-000413.  *********the serial numbers of units distributed international **************************  ARKN-000375, ARKN-000414, ARKN-000415, ARKN-000416, ARKN-000417, ARKN-000418, ARKN-000419, ARKN-000420, ARKN-000421, ARKN-000422, and ARKN-000423.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US distribution in FL, LA, MS, NC, NC, SC and WY and Internationally to Panama and United Kingdom.
  • 제품 설명
    Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for use in the hospital environment and operating room. || Absorber Adapter Assembly Service Kit, part number: 050-9045-00. || Absorber Adapter Assembly, part number: 650-1648-01. || Arkon Absorber Canister Carrier, part number: 380-0916-01.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Del Mar Reynolds Medical, Ltd., 1 2 Harforde Court John Tate Road, Business Park, Hertford United Kingdom
  • 제조사 모회사 (2017)
  • Source
    USFDA

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  • 모델명 / 제조번호(시리얼번호)
    US Serial numbers:  ARKN-000003, ARKN-000004, ARKN-000011, ARKN-000012, ARKN-000013, ARKN-000014, ARKN-000016, ARKN-000017, ARKN-000019, ARKN-000020, ARKN-000021, ARKN-000022, ARKN-000023, ARKN-000024, ARKN-000025, ARKN-000026, ARKN-000027, ARKN-000028, ARKN-000029, ARKN-000030, ARKN-000031, ARKN-000037, ARKN-000038, ARKN-000039, ARKN-000040, ARKN-000041, ARKN-000042, ARKN-000044, ARKN-000045, ARKN-000046, ARKN-000047, ARKN-000048, ARKN-000049, ARKN-000051, ARKN-000054, ARKN-000055, ARKN-000056, ARKN-000057, ARKN-000058, ARKN-000059, ARKN-000060, ARKN-000061, ARKN-000062, ARKN-000063, ARKN-000064, ARKN-000065, ARKN-000066, ARKN-000067, ARKN-000068, ARKN-000069, ARKN-000070, ARKN-000071, ARKN-000072, ARKN-000073, ARKN-000074, ARKN-000075, ARKN-000076, ARKN-000077, ARKN-000078, ARKN-000082, ARKN-000091, ARKN-000092, ARKN-000093, ARKN-000094, ARKN-000095, ARKN-000096, ARKN-000097, ARKN-000098, ARKN-000099, ARKN-000100, ARKN-000101, ARKN-000102, ARKN-000103, ARKN-000104, ARKN-000105, ARKN-000106, ARKN-000107, ARKN-000108, ARKN-000109, ARKN-000110, ARKN-000111, ARKN-000112, ARKN-000113, ARKN-000114, ARKN-000115, ARKN-000116, ARKN-000117, ARKN-000119, ARKN-000120, ARKN-000123, ARKN-000129, ARKN-000130, ARKN-000132, ARKN-000133, ARKN-000134, ARKN-000135, ARKN-000136, ARKN-000137, ARKN-000138, ARKN-000139, ARKN-000140, ARKN-000141, ARKN-000142, ARKN-000143, ARKN-000144, ARKN-000145, ARKN-000149, ARKN-000150, ARKN-000151, ARKN-000152, ARKN-000153, ARKN-000154, ARKN-000155, ARKN-000157, ARKN-000167, ARKN-000168, arkn-000169, arkn-000170, ARKN-000171, arkn-000173, arkn-000174, arkn-000175, arkn-000176, arkn-000177, arkn-000178, arkn-000179, arkn-000180, arkn-000181, arkn-000182, arkn-000183, arkn-000184, arkn-000185, ARKN-000186, ARKN-000187, ARKN-000188, ARKN-000189, ARKN-000190, ARKN-000191, ARKN-000192, ARKN-000193, ARKN-000194, ARKN-000196, ARKN-000197, ARKN-000198, ARKN-000199, ARKN-000200, ARKN-000201, ARKN-000202, ARKN-000203, ARKN-000204, ARKN-000205, ARKN-000206, ARKN-000207, ARKN-000208, ARKN-000209, ARKN-000210, ARKN-000211, ARKN-000212, ARKN-000213, ARKN-000214, ARKN-000215, ARKN-000216, ARKN-000217, ARKN-000220, ARKN-000221, ARKN-000222, arkn-000223, arkn-000224, arkn-000226, arkn-000227, arkn-000229, arkn-000230, arkn-000231, arkn-000232, arkn-000233, ARKN-000236, arkn-000237, arkn-000238, arkn-000239, arkn-000240, arkn-000241, arkn-000242, arkn-000243, arkn-000244, ARKN-000245, arkn-000248, arkn-000249, ARKN-000250, ARKN-000251, ARKN-000252, ARKN-000253, arkn-000254, arkn-000257, arkn-000258, ARKN-000259, ARKN-000260, arkn-000261, ARKN-000262, arkn-000263, arkn-000264, arkn-000266, arkn-000269, arkn-000270, arkn-000271, arkn-000272, arkn-000273, arkn-000274, arkn-000275, arkn-000276, arkn-000277, ARKN-000278, ARKN-000279, ARKN-000280, ARKN-000281, ARKN-000282, ARKN-000283, ARKN-000284, ARKN-000285, ARKN-000286, ARKN-000287, ARKN-000288, ARKN-000289, ARKN-000290, ARKN-000293, ARKN-000294, ARKN-000295, ARKN-000296, ARKN-000297, ARKN-000300, ARKN-000301, ARKN-000302, ARKN-000303, ARKN-000304, ARKN-000305, ARKN-000306, ARKN-000307, ARKN-000308, ARKN-000309, ARKN-000310, ARKN-000311, ARKN-000312, ARKN-000313, arkn-000314, arkn-000315, arkn-000316, arkn-000317, arkn-000318, ARKN-000319, arkn-000320, arkn-000321, arkn-000322, arkn-000323, arkn-000324, arkn-000325, arkn-000327, arkn-000328, arkn-000329, arkn-000330, ARKN-000332, ARKN-000333, ARKN-000334, ARKN-000335, ARKN-000336, ARKN-000337, ARKN-000338, ARKN-000339, ARKN-000340, ARKN-000341, ARKN-000342, ARKN-000343, ARKN-000344, ARKN-000345, ARKN-000353, ARKN-000360, ARKN-000361, ARKN-000362, ARKN-000363, ARKN-000364, ARKN-000365, ARKN-000366, ARKN-000367, ARKN-000369, ARKN-000370, ARKN-000371, ARKN-000372, ARKN-000373, ARKN-000374, ARKN-000376, ARKN-000377, ARKN-000378, ARKN-000379, ARKN-000380, ARKN-000381, ARKN-000382, ARKN-000383, ARKN-000384, ARKN-000385, ARKN-000386, ARKN-000387, ARKN-000388, ARKN-000389, ARKN-000390, ARKN-000391, ARKN-000392, ARKN-000393, ARKN-000394.ARKN-000395, ARKN-000396, ARKN-000397, ARKN-000398, ARKN-000399, ARKN-000400, ARKN-000401, ARKN-000402, ARKN-000403, ARKN-000404, ARKN-000405, ARKN-000406, ARKN-000407, ARKN-000408, ARKN-000409, ARKN-000410, ARKN-000411, ARKN-000412, and ARKN-000413.   ******************************************************************************** INTERNATIONAL SERIAL NUMBERS:  ARKN-000001, ARKN-000002, ARKN-000005, ARKN-000010, ARKN-000015, ARKN-000018, ARKN-000032, ARKN-000034, ARKN-000035, ARKN-000052, ARKN-000053, ARKN-000079, ARKN-000081, ARKN-000083, ARKN-000084, ARKN-000085, ARKN-000086, ARKN-000087, ARKN-000089, ARKN-000090, ARKN-000121, ARKN-000131, ARKN-000146, ARKN-000147, ARKN-000148, ARKN-000156, ARKN-000158, ARKN-000159, ARKN-000160, ARKN-000161, ARKN-000162, ARKN-000163, ARKN-000164, ARKN-000165, ARKN-000166, ARKN-000172, arkn-000218, arkn-000219, Arkn-000225, arkn-000234, arkn-000235, ARKN-000255, ARKN-000256, ARKN-000268, ARKN-000291, ARKN-000292, ARKN-000298, ARKN-000299, ARKN-000326, ARKN-000331, ARKN-000346, ARKN-000347, ARKN-000348, ARKN-000349, ARKN-000350, ARKN-000351, ARKN-000352, ARKN-000354, ARKN-000355, ARKN-000356, ARKN-000357, ARKN-000358, ARKN-000359, ARKN-000368, ARKN-000375, ARKN-000414, ARKN-000415, ARKN-000416, ARKN-000417, ARKN-000418, ARKN-000419, ARKN-000420, ARKN-000421, ARKN-000422, ARKN-000423, and ARKON-000088.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US nationwide and internationally in the following countries: BOLIVIA, CANADA, CHINA, ECUADOR, FRANCE, IRELAND, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, PANAMA, PERU, POLAND, UNITED KINGDOM.
  • 제품 설명
    Arkon Anesthesia Delivery System, Model 99999. || Product Usage: || Continuous Ventilator The Arkon Anesthesia Delivery System is designed to provide emergency oxygen, vaporized agent delivery and manual ventilation in the event of a power failure scenario. Clinicians are able to use Emergency O2 and manually ventilate the patient, providing gas and agent. However, the anesthesiologist will not have access to mechanical ventilation or ventilator monitoring.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Spacelabs Healthcare Arkon Anesthesia Delivery System
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
  • 제품 설명
    Medical Device Safety Alert: Spacelabs ARKON Anesthesia Delivery System with Version 2.0 Software
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    SERIAL NUMBERS OF UNITS DISTRIBUTED IN THE US:  ARKN-000011, ARKN-000016, ARKN-000017, ARKN-000019, ARKN-000020, ARKN-000021, ARKN-000022, ARKN-000023, ARKN-000024, ARKN-000025, ARKN-000026, ARKN-000027, ARKN-000028, ARKN-000029, ARKN-000030, and ARKN-000031.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    USA Nationwide Distribution in the states of North Carolina and South Carolina
  • 제품 설명
    SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Spacelabs: 99999, Arkon Anesthesia Delivery System
  • Manufacturer
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