A1052-22 AMNIOCENTESIS 22G QUINCKE () KIT [SMITHS MEDICAL ASD, INC.]

A1052-22 AMNIOCENTESIS 22G QUINCKE () KIT [SMITHS MEDICAL ASD, INC.]
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NDC 51688-1236-2, 52380-0001-3
Set ID d9f0d3ba-1785-4613-9fc3-359d917b1ada
Category MEDICAL DEVICE
Packager Smiths Medical ASD, Inc.
Generic Name
Product Class
Product Number
Application Number HIO
  • 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

  • PRINCIPAL DISPLAY PANEL

    Package Label Display Panel

    A1052-22

  • INGREDIENTS AND APPEARANCE
    A1052-22 AMNIOCENTESIS 22G QUINCKE 
    sampler, amniotic fluid (amniocentesis tray) kit
    Product Information
    Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:51688-1236
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:51688-1236-210 in 1 CASE
    11 in 1 PACKAGE, COMBINATION
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 PACKET 22.5 mL
    Part 1 of 1
    APLICARE POVIDONE-IODINE  
    povidone-iodine solution
    Product Information
    Item Code (Source)NDC:52380-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52380-0001-322.5 mL in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/01/1984
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    exempt deviceHIO12/14/2005
    Labeler - Smiths Medical ASD, Inc. (137835299)
    Establishment
    NameAddressID/FEIBusiness Operations
    Smiths Medical ASD, Inc.137835299manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Aplicare, Inc.107255002manufacture

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