Convenience Kit

  • Modelo / Serial
    Part No. K07-00116AP, Lot Nos A340949, A346191. Part No. K09-00302FP, Lot # A340485, A341488 Part No. K09-00579CP, Lot # A339214, A345673 Part No. K09-00585LP, Lot # A338201, A344694 Part No. K09-00759DP, Lot #A342359, A345674,   A347263. Part No. K09-00946MP, Lot # A341491 Part No. K09-00970K, Lot # A337245 Part No. K09-01574G, Lot # A343825 Part No. K09-01673H, Lot # A342676 Part No. K09-01908AP, Lot # A338729, A344187,   A344382. Part No. K09-02104HP, Lot # A337839, A346138 Part No. K09-02249H, Lot # A343819 Part No. K09-02249HP, Lot # A339688 Part No. K09-02334K, Lot # A345405 Part No. K09-02353G, Lot # A342675 Part No. K09-03242C, Lot # A342165 Part No. K09-03528D, Lot # A341710 Part No. K09-03978HP, Lot # A339229, A340896,  A344386. Part No.K09-04000HP, Lot # A338208, A339231,  A341504, A344612,  A341505, A341504. Part No. K09-04017C, Lot # A337857 Part No. K09-04316H, Lot # A342071. Part No. K09-04488A, Lot # A338228, A341118. Part No. K09-04863C, Lot # A337204, A338112. Part No. K09-04863C, Lot # A337204. Part No. K09-04923B, Lot # A340508, A 343196. Part No. K09-05138CP, Lot # A339425, A342802. Part No. K09-05229G, Lot # A339926. Part No. K09-05229GP, Lot # A345552. Part No. K09-05477A, Lot # A342803. Part No. K09-05785DP, Lot # A340897. Part No. K09-05939C, Lot # A337947, A342379. Part No. K09-05947D, Lot # A342670. Part No. K09-06262P, Lot # A341604. Part No. K09-07470C, Lot # A342173. Part No. K09-07547B, Lot # A340375. Part No. K09-07573AP, Lot # A344373. Part No. K09-07573P, Lot # A342349. Part No. K09-07589P, Lot # A347257, A347985. Part No. K09-07629CP, Lot # A344853. Part No. K09-07746A, Lot # A337319. Part No. K09-07759, Lot # A341614.  Part No. K09-07779P, Lot # A344855, A347876. Part No. K09-07847, Lot # A342385. Part No. K09-07883B, Lot # A336474. Part No. K09-07924AP, Lot # A346124. Part No. K09-07943AP, Lot # A345851. Part No. K09-07944A, Lot # A339427. Part No. K09-08020B, Lot # A331903. Part No. K09-08065P, Lot # A345570. Part No. K09-08150AP, Lot # A340352, A342387. Part No. K09-08214B, Lot # A340534 Part No. K09-08369, Lot # A342388. Part No. K09-08391AP, Lot # A340252, A343600. Part No. K09-08397, Lot # A335968. Part No. K09-90270KP, Lot # A3412623, A343596. Part No. K09-90358DP, Lot # A345692. Part No. K09-MS2366H, Lot # A341693. Part No. K09-MS2450B, Lot # A338759. Part No. K09-MS2550A, Lot # A343809. Part No. K09-MS2602A, Lot # A342813. Part No. K09-MS2638B, Lot # A341694, Part No. K09-MS2703B, Lot # A336929, A343808. Part No. K10-01223B, Lot # A339948. Part No. K10-03441P, Lot # A336328, A343551. Part No. K10-03616, Lot # A339959. Part No. K12-01176B, Lot # AS345883.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide. One VA facility in NC, one military hospital in GA. Foreign distribution to Canada, France, Japan, Netherlands.
  • Descripción del producto
    Convenience Kits containing Inject8 or Inject10 syringes.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Merit Medical Systems, Inc, 1600 Merit Pkwy, South Jordan UT 84095-2416
  • Source
    USFDA

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Más información acerca de la data acá

  • Modelo / Serial
    Model Number: K04-00278/A. Lot Numbers: A253131.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    FL and Japan.
  • Descripción del producto
    Custom Angiographic Kit.
  • Manufacturer
  • Modelo / Serial
    Model Number: K08-MP5130. Lot Numbers: A146066, A188604.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    FL and Japan.
  • Descripción del producto
    Custom Angiographic Kit
  • Manufacturer
  • Modelo / Serial
    Model Number: K11-MPT2023/D. Lot Numbers: A145200, A156200, A191561.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    FL and Japan.
  • Descripción del producto
    Custom Angiographic Kit
  • Manufacturer
  • Modelo / Serial
    REF/CAT No.: K09-03442C. Lot No. A259058
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide. Foreign distribution to France, Malaysia, Taiwan, Dominican Republic.
  • Descripción del producto
    Custom Kit
  • Manufacturer
  • Modelo / Serial
    Lot # A286536 # A286573  #A284710, #A286572, #A284696, #A286544, #A289876, #A286529, #A286569, #A286538 #A290146, #A287547, #A284668, #A286552 #A284703, #A287540, #A286565, #A284616  #A284618, #A286535, #A286547, #A284998  #A284694, #A284617, #A286560, #A286542  #A286550, #A287554, #A287553, #A279791 #A290033, #A290053, #A286541, and #A283067.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed nationwide. International distribution includes Canada, Japan, Korea, England and France.
  • Descripción del producto
    Inflation Kit. Label reads in part: ''CUSTOM KIT...MERIT MEDICAL''. Latex free, Sterile if package is unopened or undamaged. Part Numbers: K05-00122H, K05-50031D, K0510570, K05-01536A, K05-01153C, K05-00276C, K05-0019313, K05-00077F, K05-01296A, K05-00134D, K05-01676, K05-01250, K05-00800, K05-01545, K05-00819, K05-01069C, K05-00559F, K05-50078B, K05-00116C, K05-00459C, K05-01290A,K05-01146, K05-50054D, K05-00946B, K05-00203K, K05-00682B, || K05-YSI008A, K05-YPI011, K05-00746, K05-003139, K05-00751G,K05-00180G, and K05-00553F.
  • Manufacturer
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