G1477 ANAEROBIC PULSATOR ARTERIAL BLOOD SAMPLING KIT WITH LIQUID SODIUM HEPARIN FOR GASES AND ELECTROLYTES () KIT [SMITHS MEDICAL ASD, INC.]

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G1477 ANAEROBIC PULSATOR ARTERIAL BLOOD SAMPLING KIT WITH LIQUID SODIUM HEPARIN FOR GASES AND ELECTROLYTES () KIT [SMITHS MEDICAL ASD, INC.]
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NDC 51688-5275-6, 52380-0111-1
Set ID b7dfcc5b-b9a1-41d4-96b7-d11505b11b9a
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

    G1477

  • INGREDIENTS AND APPEARANCE
    G1477 ANAEROBIC PULSATOR ARTERIAL BLOOD SAMPLING KIT WITH LIQUID SODIUM HEPARIN FOR GASES AND ELECTROLYTES 
    tubes, vials, systems, serum separators, blood collection kit
    Product Information
    Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:51688-5275
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:51688-5275-6100 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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