G1585 PULSATOR ARTERIAL BLOOD SAMPLING KIT WITH LIQUID SODIUM HEPARIN () KIT [SMITHS MEDICAL ASD, INC.]

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  • G1585 PULSATOR ARTERIAL BLOOD SAMPLING KIT WITH LIQUID SODIUM HEPARIN () KIT [SMITHS MEDICAL ASD, INC.]

G1585 PULSATOR ARTERIAL BLOOD SAMPLING KIT WITH LIQUID SODIUM HEPARIN () KIT [SMITHS MEDICAL ASD, INC.]
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NDC 51688-4255-6, 52380-0111-1
Set ID d45bd6e7-d8b0-4b21-8f36-95bc6fdf029f
Category MEDICAL DEVICE
Packager Smiths Medical ASD, Inc.
Generic Name
Product Class
Product Number
Application Number K840986
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  • Drug Facts

    Povidone-iodine

  • PURPOSE

    Antiseptic

    Antiseptic 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 wounds

    - puncture wounds

    - serious burns

  • STOP USE

    Stop use and ask a doctor if

    - infection occurs

    - redness, irritation, swelling or pain persists or increases

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

    Avoid excessive heat.

    Store at room temperature.

  • INSTRUCTIONS FOR USE

    Apply locally as needed.

  • OTHER SAFETY INFORMATION

    • 1% titratable iodine
    • Latex free
    • For hospital or professional use only
  • INACTIVE INGREDIENT

    citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water

  • PRINCIPAL DISPLAY PANEL

    APLICARE

    POVIDONE-IODINE PREP PAD

    ANTISEPTIC

    STERILE SOLUTION

    Povidone-Iodine Prep Pad

  • PRINCIPAL DISPLAY PANEL

    Package Label Display Panel

    G1585

  • INGREDIENTS AND APPEARANCE
    G1585 PULSATOR ARTERIAL BLOOD SAMPLING KIT WITH LIQUID SODIUM HEPARIN 
    tubes, vials, systems, serum separators, blood collection kit
    Product Information
    Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:51688-4255
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:51688-4255-6100 in 1 CASE
    11 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 PACKET 1 mL
    Part 1 of 1
    APLICARE POVIDONE-IODINE 
    povidone-iodine solution
    Product Information
    Item Code (Source)NDC:52380-0111
    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:52380-0111-11 mL in 1 PACKET; Type 0: Not a Combination Product
    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
    premarket notificationK84098612/14/2005
    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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