Arrow

  • Model / Serial
    Product No. AP-01013. Lot Numbers: 11284, MF3085483, MF4031500, MF4063259.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide. The firm is NOT recalling from international accounts.
  • Product Description
    Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. || Ref Product No. AP-01013 || Latex-Free Low Profile Port
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Arrow International Inc, 2400 Bernville Rd, Reading PA 19605-9607
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

570 devices with a similar name

Learn more about the data here

  • Model / Serial
    Material Number CDA-25123-1A
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit || The large-bore multiple-lumen catheter permits venous access to the central circulation for rapid fluid administration
  • Manufacturer
  • Model / Serial
    Material Number CDA-44041-HPK1A
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Arrow PICC with Chlorag+ard Technology || A PICC permits venous access to the central circulation through a peripheral vein
  • Manufacturer
  • Model / Serial
    4799431
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AL, AK, AZ AR, CA, CO, CT, FL, GA, HI, ID, IL IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY, Canada and Costa Rica
  • Product Description
    Arrow EZ-IO Needle Set 45 mm 15 ga, Ref 9079.
  • Manufacturer
  • Model / Serial
    Product Codes ASK-45703-PRWJ1, ASK-45703-PUAB1, and ASK-45703-PUPM  Lot # 13F16L0105, 23F16K0180 and 13F16L0199
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to NJ, IL, and PA
  • Product Description
    Pressure Injectable Arrowg+ard Blue Plus Multi-Lumen Central Venous Catheterization Kit. || Permits venous access to central circulation by way of subclavian, jugular and femoral veins. The ARROWg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (>30 days). Clinical effectiveness of the ARROW g+ard Blue Plus catheter in preventing CRBSIs compared to the original ARROWg+ard Blue catheter has not been studied
  • Manufacturer
  • Model / Serial
    510K # K002507, Material # ASK-21142-HF3
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters || The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The ARROWg+ard(R) technology is intended to help provide protection against catheter-related infections. Clinical data have not been collected that demonstrate the use of the ARROWg+ard(R) antimicrobial surface in decreasing catheter-related infections for this device. It is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.
  • Manufacturer
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