Arrow

  • Modèle / numéro de série
    Product No. AP-06528. Lot Number: 12054, MF3033635, MF3075166, MF3095536, MF3105900, MF3116038, MF4016607, MF4020455, MF4020838, MF4063175, MF4073793, MF4084293, MF4084406, MF4105408, MF5017415, MF5049326, MF6014778, MF6068936, MF6079334.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide. The firm is NOT recalling from international accounts.
  • Description du dispositif
    Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. || Latex-Free A(2) Port , 12 Fr. Introducer Kit. || Ref Product Code: AP-06528
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Arrow International Inc, 2400 Bernville Rd, Reading PA 19605-9607
  • Société-mère du fabricant (2017)
  • Source
    USFDA

570 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Catalog numbers AK-07903-AG, SI-07903-AG, JM-07903-AG, and CI-07903-AG.
  • Classification du dispositif
  • Distribution
    The products were shipped to hospitals, distributors, dealers and sales representatives nationwide. The product was also shipped to export dealers in Finland, Australia, Italy, Brazil, Taiwan, New Zealand, Poland, United Kingdom, and Belgium and subsidiaries in Germany, France, Africa, Canada, Netherlands, SPain, and Greece.
  • Description du dispositif
    9 French Super Arrow-Flex Percutaneous Sheath Introducer Kit with Arrowg and Blue Antimicrobial Surface Sheath
  • Manufacturer
  • Modèle / numéro de série
    AP-06520 MF3074927  MF3075118  MF3085217  MF3085281  MF3095491  MF3095574  MF3095611
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Product was distributed internationally (France, Germany, Mexico, United Kingdom, Singapore, Brazil, Australia) and domestically. Domestic distribution was concentrated in the Midwest and Eastern portions of the US. Total direct accounts : Distributors/dealers, international - 7 Distributors/dealers, domestic - 5 Hospitals, domestic -36 Approximate percentage of each type of consignee: Distributors/dealers, international - 14.6% Distributors/dealers, domestic - 10.4% Hospitals, domestic - 75% Percentage of product sent to each type of consignee : Distributors/dealers, international - 70.8% Distributors/dealers, domestic - 7.9% Hospitals, domestic - 21.3% No VA or government contracts.
  • Description du dispositif
    Arrow A Port with Attachable Silicone Rubber Catheters/10 Fr. || Introducer Kit Implantable Vascular Access System (Product # AP-06520) || Product # AP-06520 kit contains 1 implantable titanium port, 2 attachable silicone rubber catheters (8.4 Fr. x 75 cm and 9.6 Fr x 75 cm), 10 Fr. Introducer kit (spring-wire guide, introducer needle, sheath), straight non-coring needle, syringe, tunneling instrument, drape, patient ID card and chart sticker. Kit sold individually or per case (5 trays/case).
  • Manufacturer
  • Modèle / numéro de série
    AP-01510 MF3085292  MF3085315  MF3095551  MF3095651
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Product was distributed internationally (France, Germany, Mexico, United Kingdom, Singapore, Brazil, Australia) and domestically. Domestic distribution was concentrated in the Midwest and Eastern portions of the US. Total direct accounts : Distributors/dealers, international - 7 Distributors/dealers, domestic - 5 Hospitals, domestic -36 Approximate percentage of each type of consignee: Distributors/dealers, international - 14.6% Distributors/dealers, domestic - 10.4% Hospitals, domestic - 75% Percentage of product sent to each type of consignee : Distributors/dealers, international - 70.8% Distributors/dealers, domestic - 7.9% Hospitals, domestic - 21.3% No VA or government contracts.
  • Description du dispositif
    Arrow A Port with Attachable Silicone Rubber Catheters Implantable Vascular Access System (Product # AP-01510) . || Product # AP-01510 kit contains 1 implantable titanium port, 2 attachable silicone rubber catheters (8.4 Fr. x 75 cm and 9.6 Fr x 75 cm) straight non-coring needle, patient ID card and chart sticker. Kit sold individually or per case (5 trays/case).
  • Manufacturer
  • Modèle / numéro de série
    AP-06042 MF3075086  MF3075140  MF3085285
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Product was distributed internationally (France, Germany, Mexico, United Kingdom, Singapore, Brazil, Australia) and domestically. Domestic distribution was concentrated in the Midwest and Eastern portions of the US. Total direct accounts : Distributors/dealers, international - 7 Distributors/dealers, domestic - 5 Hospitals, domestic -36 Approximate percentage of each type of consignee: Distributors/dealers, international - 14.6% Distributors/dealers, domestic - 10.4% Hospitals, domestic - 75% Percentage of product sent to each type of consignee : Distributors/dealers, international - 70.8% Distributors/dealers, domestic - 7.9% Hospitals, domestic - 21.3% No VA or government contracts.
  • Description du dispositif
    Arrow Low Profile Port with Attachable Silicone Rubber Catheters/10 Fr. Introducer Kit Implantable (Product # AP-06042) [NB: titanium port]. || Product # AP-06042 kit contains 1 low profile implantable titanium port, 2 attachable silicone rubber catheters (8.4 Fr. x 75 cm and 9.6 Fr x 75 cm), 10 Fr. Introducer kit (spring-wire guide, introducer needle, sheath), injection needle, syringe, tunneling instrument, drape, patient ID card and chart sticker. Kit sold individually or per case (5 trays/case).
  • Manufacturer
  • Modèle / numéro de série
    AP-06022 MF3075080  MF3085227  MF3085410
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Product was distributed internationally (France, Germany, Mexico, United Kingdom, Singapore, Brazil, Australia) and domestically. Domestic distribution was concentrated in the Midwest and Eastern portions of the US. Total direct accounts : Distributors/dealers, international - 7 Distributors/dealers, domestic - 5 Hospitals, domestic -36 Approximate percentage of each type of consignee: Distributors/dealers, international - 14.6% Distributors/dealers, domestic - 10.4% Hospitals, domestic - 75% Percentage of product sent to each type of consignee : Distributors/dealers, international - 70.8% Distributors/dealers, domestic - 7.9% Hospitals, domestic - 21.3% No VA or government contracts.
  • Description du dispositif
    Arrow Low Profile Port with Attachable Silicone Rubber Catheters/10 Fr. || Introducer Kit Implantable Vascular Access System (Product # AP-06022) [NB: || plastic port] || Product # AP-06022 kit contains 1 low profile implantable plastic port, 2 attachable silicone rubber catheters (8.4 Fr. x 75 cm and 9.6 Fr x 75 cm), 10 Fr. Introducer kit (spring-wire guide, introducer needle, sheath), straight non-coring needle, syringe, tunneling instrument, drape, patient ID card and chart sticker. Kit sold individually or per case (5 trays/case).
  • Manufacturer
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