Devices

AirLife

  • 모델명 / 제조번호(시리얼번호)
    1) Product Code 2K8005; Lot Numbers: 0000355656, 0000355659, 0000355662, 0000355664, 0000355665, 0000355666, 0000355668;  2) Product Code 2K8004; Lot Number: 0000355673;  3) Product Code 2K8017; Lot Numbers: 0000355676, 0000355677;  4) Product Code 2K8034; Lot Number: 0000355688;  5) Product Code 2K8035; Lot Number: 0000358023;  6) Product Code 2K8037; Lot Number: 0000358025;  7) Product Code 2K8040; Lot Number: 0000358026
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide in the states of AZ, CA, CO, DE, FL, GA, IL, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NM, NY, OH, PA, TX, UT, WA
  • 제품 설명
    1) Adult Manual Resuscitator, 2K8004, Oxygen Reservoir Bag, Adult Mask; || 2) Adult Manual Resuscitator, 2K8005, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask; || 3) Adult Manual Resuscitator, 2K8017, Variable Volume Oxygen Reservoir Tubing, Adult Mask; || 4) Adult Manual Resuscitator, 2K8034, 40" (1.0 m) Oxygen Reservoir Tubing, PEEP Valve, without Mask; || 5) Adult Manual Resuscitator, 2K8035, Oxygen Reservoir Bag, PEEP Valve, Adult Mask; || 6) Pediatric Manual Resuscitator, 2K8037, 40" (1.0 m) Oxygen Reservoir Tubing, PEEP Valve, Pediatric Mask, Pressure Limiting Valve with Lock; || 7) Infant Manual Resuscitator, 2K8040, Oxygen Reservoir Bag, PEEP Valve, Infant Mask, Pressure Limiting Valve with Lock || Product Usage: Pulmonary resuscitation
  • Manufacturer
    Carefusion 2200 Inc
  • 1 Event

제조사

Carefusion 2200 Inc
  • 제조사 주소
    Carefusion 2200 Inc, 1500 S Waukegan Rd, Mpwm Bldg., Waukegan IL 60085-6728
  • 제조사 모회사 (2017)
    Becton, Dickinson and Company
  • Source
    USFDA

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AIRLIFE INSPIRATORY FORCE PRESSURE ADAPTER
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 5925-504 (Lot serial: ALL LESS THAN LOT #000415257); Model Catalog: 5925-504 (Lot serial: ALL STARTING WITH THE LETTER Y); Model Catalog: 5925-504 (Lot serial: OR); Model Catalog: 1209-503 (Lot serial: OR); Model Catalog: 1208-4H1 (Lot serial: OR); Model Catalog: 10127-4H1 (Lot serial: OR); Model Catalog: RC41-12027 (Lot serial: ALL STARTING WITH THE LETTER Y); Model Catalog: 9054-4S2 (Lot serial: ALL STARTING WITH THE LETTER Y); Model Catalog: 9053-4S2 (Lot serial: ALL STARTING WITH THE LETTER Y); Model Catalog: 9052-4S2 (Lot serial: ALL STARTING WITH THE LETTER Y); Model Catalog: 6800-503 (Lot serial: ALL STARTING WITH THE LETTER Y); Model Catalog: 5732-4H1 (Lot serial: ALL STARTING WITH THE LETTER Y); Model Catalog: 5682-409 (Lot serial: ALL STARTING WITH THE LETTER Y); Model Catalog: 1553-4H1 (Lot serial: ALL STARTING WITH THE LETTER Y); Model Catalog: 7441-4S2 (Lot serial: ALL STARTING WITH THE LETTER Y); Model Catalog: 1209-503 (Lot serial: ALL STARTING WITH THE LETTER Y); Model Catalog:
  • 제품 설명
    AirLife Isothermal Breathing Circuit Accessory- Infant Patient Connector
  • Manufacturer
    CARDINAL HEALTH CANADA INC.
AIRLIFE INFANT MANUAL RESUSCITATOR
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 2K8019 (Lot serial: ); Model Catalog: 2K8021 (Lot serial: ); Model Catalog: 2K8032 (Lot serial: 1006144); Model Catalog: 2K8032 (Lot serial: 944381); Model Catalog: 2K8032 (Lot serial: 969802); Model Catalog: 2K8032 (Lot serial: 963263); Model Catalog: 2K8032 (Lot serial: 924302); Model Catalog: 2K8032 (Lot serial: 10115634); Model Catalog: 2K8032 (Lot serial: 933592); Model Catalog: 2K8032 (Lot serial: 911374); Model Catalog: 2K8032 (Lot serial: 1022517); Model Catalog: 2K8018 (Lot serial: 1013510); Model Catalog: 2K8020 (Lot serial: 1013510); Model Catalog: 2K8039 (Lot serial: 1013510); Model Catalog: 2K8018 (Lot serial: 1018801); Model Catalog: 2K8020 (Lot serial: 1018801); Model Catalog: 2K8039 (Lot serial: 1018801); Model Catalog: 2K8018 (Lot serial: 1018700); Model Catalog: 2K8020 (Lot serial: 1018700); Model Catalog: 2K8039 (Lot serial: 1018700); Model Catalog: 2K8032 (Lot serial: 1029206); Model Catalog: 7730POCH (Lot serial: 993427); Model Catalog: 7730IALS (Lot serial: 1082819)
  • 제품 설명
    AIRLIFE INFANT MANUAL RESUSCITATOR
  • Manufacturer
    CAREFUSION
AIRLIFE ADULT MANUAL RESUSCITATOR
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 2K8032 (Lot serial: FOR 2K8000 & 2K8032-ANY LOT); Model Catalog: 2K8017 (Lot serial: FOR 2K8000 & 2K8032-ANY LOT); Model Catalog: 2K8005 (Lot serial: FOR 2K8000 & 2K8032-ANY LOT); Model Catalog: 2K8000 (Lot serial: FOR 2K8000 & 2K8032-ANY LOT); Model Catalog: 2K8032 (Lot serial: 57.); Model Catalog: 2K8017 (Lot serial: 57.); Model Catalog: 2K8005 (Lot serial: 57.); Model Catalog: 2K8000 (Lot serial: 57.); Model Catalog: 2K8032 (Lot serial: ALL LOTS BETWEEN Y1B0000-Y1B02); Model Catalog: 2K8017 (Lot serial: ALL LOTS BETWEEN Y1B0000-Y1B02); Model Catalog: 2K8005 (Lot serial: ALL LOTS BETWEEN Y1B0000-Y1B02); Model Catalog: 2K8000 (Lot serial: ALL LOTS BETWEEN Y1B0000-Y1B02); Model Catalog: 2K8032 (Lot serial: 04440 04401 04634.); Model Catalog: 2K8017 (Lot serial: 04440 04401 04634.); Model Catalog: 2K8005 (Lot serial: 04440 04401 04634.); Model Catalog: 2K8000 (Lot serial: 04440 04401 04634.); Model Catalog: 2K8032 (Lot serial: BEGINNING WITH Y9 Y0 Y1A); Model Catalog: 2K8017 (Lot serial: BEGINN
  • 제품 설명
    ADULT AIRLIFE MANUAL RESUSCITATOR
  • Manufacturer
    CARDINAL HEALTH CANADA INC.
Device Recall AirLife nCPAP System Driver
  • 모델명 / 제조번호(시리얼번호)
    Catalog Number 006900, Firmware Version 2.02 with the following Serial Numbers: 0107DL002, 0107DL003, 0107DL004, 0107DL011, 0107DL008, 0606DL001, 0606DL002, 0606DL009, 0606DL012, 0606DL013, 0606DL014, 0606DL015, 0606DL017, 0606DL018, 0606DL019, 0606DL021, 0606DL022, 0606DL023, 0606DL024, 0606DL025, 0606DL026, 0606DL027, 0606DL033, 0606DL040, 1106DL001, 1106DL002, 1106DL003, 1106DL004, 1106DL005, 1106DL006, 1106DL007, 1106DL008, 1106DL009, 1106DL010, 1106DL011, 1106DL012, 1106DL013, 1106DL014, 1106DL015, 1106DL016, 1106DL017, 1106DL018, 1106DL019, 1106DL020, 1206DL001, 1206DL002, 1206DL003, 1206DL004, 1206DL005, 1206DL006, 1206DL007, 1206DL008, 1206DL009, 1206DL010, 1206DL011, 1206DL012, 1206DL013, 1206DL014, 1206DL015, 1206DL017, 1206DL018, 1206DL019, 1206DL020, 1206DL022, 1206DL023, 1206DL025, 1206DL016
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide.
  • 제품 설명
    AirLife nCPAP System Driver; a nasal continuous positive airway pressure device, which is part of a larger system that includes an nCPAP generator, fixation device and patient interface (prongs and.or mask); Cardinal Health, McGaw Park, IL 60085; cat. 006900
  • Manufacturer
    Cardinal Health
Device Recall AirLife Infant nCPAP System Driver
  • 모델명 / 제조번호(시리얼번호)
    Catalog Number 006900, Firmware Version 2.02.39 with the following Serial Numbers: 0107DL001, 0107DL002A, 0107DL003, 0107DL004A, 0107DL005, 0107DL006, 0107DL007, 0107DL008A, 0107DL009, 0107DL010, 0107DL011A, 0107DL012, 0107DL013, 0107DL014, 0107DL015, 0107DL016, 0107DL017, 0107DL018, 0107DL019, 0107DL020, 0107DL021, 0107DL022, 0107DL023, 0107DL024, 0107DL025, 0107DL026, 0107DL027, 0107DL028, 0107DL029, 0107DL030, 0206DL001, 0206DL002, 0206DL003, 0206DL004, 0206DL005, 0206DL006, 0207DL001, 0207DL002, 0207DL003, 0207DL004, 0207DL005, 0207DL006, 0306DL001, 0306DL002, 0306DL003, 0507DL007, 0507DL008, 0507DL009, 0507DL010, 0507DL011, 0507DL012, 0507DL013, 0507DL014, 0507DL015, 0507DL016, 0507DL017, 0507DL018, 0507DL019, 0507DL020, 0507DL021, 0507DL022, 0507DL023, 0507DL024, 0507DL025, 0507DL026, 0507DL027, 0507DL028, 0507DL029, 0507DL030, 0507DL031, 0507DL032, 0507DL033, 0507DL034, 0507DL035, 0507DL036, 0507DL037, 0507DL038, 0507DL039, 0507DL040, 0507DL041, 0507DL042, 0606DL001, 0606DL002A, 0606DL003, 0606DL004, 0606DL005, 0606DL006, 0606DL007, 0606DL008, 0606DL009A, 0606DL010, 0606DL011, 0606DL012A, 0606DL013, 0606DL014A, 0606DL015, 0606DL016, 0606DL017A, 0606DL018, 0606DL019A, 0606DL020, 0606DL021A, 0606DL022A, 0606DL023A, 0606DL024A, 0606DL025A, 0606DL026A, 0606DL027A, 0606DL028, 0606DL029, 0606DL030, 0606DL031, 0606DL032, 0606DL033A, 0606DL034, 0606DL035, 0606DL036, 0606DL037, 0606DL038, 0606DL039, 0606DL040, 0607DL043, 0607DL044, 0607DL045, 0607DL046, 0607DL047, 0607DL048, 0607DL049, 0607DL050, 0607DL051, 0607DL052, 0607DL053, 0607DL054, 0607DL055, 0607DL056, 0607DL057, 0607DL058, 0607DL059, 0607DL060, 0607DL061, 0607DL062, 0607DL063, 0607DL064, 0607DL065, 0607DL066, 0607DL067, 0607DL068, 0607DL069, 0607DL070, 0607DL071, 0607DL072, 0607DL073, 0607DL074, 0607DL075, 0607DL076, 0607DL077, 0607DL078, 0607DL079, 0607DL080, 0607DL081, 0607DL082, 0607DL083, 0607DL084, 0607DL085, 0607DL086, 0607DL087, 0607DL088, 0707DL089, 0707DL090, 0707DL091, 0707DL092, 0707DL093, 0707DL094, 0707DL095, 0707DL096, 0707DL097, 0707DL098, 0707DL099, 0707DL100, 0707DL101, 0707DL102, 0707DL103, 0707DL104, 0707DL105, 0707DL106, 0707DL107, 0707DL108, 0707DL109, 0707DL110, 0707DL111, 0707DL112, 0707DL113, 0707DL114, 0707DL115, 0707DL116, 0707DL117, 0707DL118, 0707DL119, 0707DL120, 0707DL121, 0707DL122, 0707DL123, 0707DL124, 0707DL125, 0707DL126, 0707DL127, 0707DL128, 0707DL129, 0707DL130, 0707DL131, 0707DL132, 0707DL133, 0707DL134, 0707DL135, 0707DL136, 0707DL137, 0707DL138, 0707DL139, 0707DL140, 1106DL001, 1106DL002, 1106DL003, 1106DL004, 1106DL005A, 1106DL006, 1106DL007A, 1106DL008, 1106DL009, 1106DL010A, 1106DL011, 1106DL012A, 1106DL013, 1106DL014A, 1106DL015A, 1106DL016, 1106DL017, 1106DL018, 1106DL019, 1106DL020, 1107DL133, 1107DL134, 1107DL135, 1107DL141, 1107DL142, 1107DL143, 1107DL144, 1107DL145, 1107DL146, 1107DL147, 1107DL148, 1107DL149, 1107DL150, 1107DL151, 1107DL152, 1107DL153, 1107DL154, 1107DL155, 1107DL156, 1107DL157, 1107DL158, 1107DL159, 1107DL160, 1107DL161, 1107DL162, 1107DL163, 1107DL164, 1107DL165, 1107DL166, 1206DL001A, 1206DL002A, 1206DL003A, 1206DL004A, 1206DL005A, 1206DL006A, 1206DL007A, 1206DL008A, 1206DL009A, 1206DL010, 1206DL011, 1206DL012A, 1206DL013A, 1206DL014, 1206DL015, 1206DL016A, 1206DL017, 1206DL018A, 1206DL019A, 1206DL020, 1206DL021, 1206DL022A, 1206DL023, 1206DL024, 1206DL025A, 1207DL167, 1207DL168, 1207DL169, 1207DL170, 1207DL171, 1207DL172, 1207DL173, 1207DL174, 1207DL175, 1207DL176, 1207DL177, 1207DL178, 1207DL179, 1207DL180, 1207DL181, 1207DL182, 1207DL183, 1207DL184, 1207DL185, 1207DL186, 1207DL187, 1207DL188, 1207DL189, 1207DL190, 1207DL191, 1207DL192, 1207DL193, 1207DL194, 1207DL195, 1207DL196, 1207DL198, and 1207DL199
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution
  • 제품 설명
    AirLife Infant nCPAP System Driver (Catalog No: 006900;) a nasal continuous positive airway pressure device, which is part of a larger system that includes an Infant Nasal CPAP generator, fixation device and patient interface (prongs and/or mask); Cardinal Health, McGaw Park, IL 60085
  • Manufacturer
    Cardinal Health
하나 더 45 건 더