Label: A1052-22 AMNIOCENTESIS 22G QUINCKE- sampler, amniotic fluid (amniocentesis tray)

  • NDC Code(s): 51688-1236-2, 52380-0001-3
  • Packager: Smiths Medical ASD, Inc.
  • Category: MEDICAL DEVICE
  • DEA Schedule: None
  • Marketing Status: Exempt device

Drug Label Information

Updated 08/14

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  • PRINCIPAL DISPLAY PANEL

    APLICARE POVIDONE-IODINE SOLUTION (povidone-iodine solution) solution
    [Aplicare, Inc.]

    3/4 Ounce Povidone Iodine Packet

    Active Ingredient
    Povidone-iodine
    Purpose
    Antiseptic
    Use
    Antispetic skin preparation
    Warnings
    Do not use
    -if allergic to iodine.
    -in the eyes
    For external use only.
    Ask a doctor before use if injuries are
    -deep or puncture wounds
    -serious burns
    Stop use and ask a doctor if
    -redness, irritation, swelling or pain persists or increases
    -infection occurs
    Keep out of reach of children
    In case of accidental ingestion, seek professional help or consult a poison control center immediately.
    Directions
    Apply locally as needed.
    Inactive Ingredients
    citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water
    Questions or comments?
    1 800 760-3236 (Mon to Fri 8:30 AM-5:00 PM EST)

    Povidone Iodine Solution

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  • PRINCIPAL DISPLAY PANEL

    Package Label Display Panel

    A1052-22

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  • INGREDIENTS AND APPEARANCE
    A1052-22 AMNIOCENTESIS 22G QUINCKE 
    sampler, amniotic fluid (amniocentesis tray) kit
    Product Information
    Product Type MEDICAL DEVICE Item Code (Source) NHRIC:51688-1236
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NHRIC:51688-1236-2 10 in 1 CASE
    1 1 in 1 PACKAGE, COMBINATION
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 PACKET 22.5 mL
    Part 1 of 1
    APLICARE POVIDONE-IODINE  
    povidone-iodine solution
    Product Information
    Item Code (Source) NDC:52380-0001
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    POVIDONE-IODINE (IODINE) IODINE 10 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE  
    SODIUM PHOSPHATE, DIBASIC  
    SODIUM HYDROXIDE  
    NONOXYNOL-9  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52380-0001-3 22.5 mL in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 03/01/1984
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    exempt device HIO 12/14/2005
    Labeler - Smiths Medical ASD, Inc. (137835299)
    Establishment
    Name Address ID/FEI Business Operations
    Smiths Medical ASD, Inc. 137835299 manufacture
    Establishment
    Name Address ID/FEI Business Operations
    Aplicare, Inc. 107255002 manufacture
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