Label: STOOL COLLECTION KIT FOR GI MOLECULAR TEST- kit

  • Category: MEDICAL DEVICE
  • DEA Schedule: None
  • Marketing Status: Exempt device

Drug Label Information

Updated September 1, 2015

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  • KIT Includes

    • Lab Tissue Mailer, Overall Height 3-7/8 In., Overall Length 4-1/8 In., Zoro Number: G3670484, Mfr Number: 729/CP; Qty-1
    • "Mini Ice Pack from an Ice pack Sqaure Mat, Length 16-1/2 In., Width 14-3/4 In., Height 14-3/4 In., Zoro #: G5830133 | Mfr #: 405SQ ( each matt has 60 pieces, which only one small piece is used)
    • Mailing Carton, Capacity 72 cu. in., Color White, Inside Width 4 In., Inside Length 6 In., Inside Depth 3 In,Zoro#: G1072556 | Mfr#: 0101-1681010; Qty-1
    • One 3ml transfer pipette; Transfer Pipet, 3.0mL, Small Bulb, Graduated to 1mL, 140mm, Bulb Draw - 2.2mL, globe scientific, item#137035; Qty-1
    • One pair of medium latex free gloves
    • Bag, Biohazard Specimen Transport, 6" x 9", Ziplock with Document Pouch, Globe scientific,item#4919; Qty-1
    • Container, Fecal, 30mL, attached Screw Cap with Spoon, PP, Conical Bottom, Self-Standing, globe scientific, item#109120; Qty-1
    • Sterile cotton tipped applicators, Dynarexcorporation, 2 X 6"inch, reorder no. 4305, lot: 25519; Qty-1
    • Microtube, 1.5mL, Self-Standing, Attached Screw Cap for Color Insert, with O-Ring, STERILE, PP, globe scientific, item#111720; Qty-2
    • Alcohol pads: PT# 5110 PT# # 5110- Prep Surgical Alcohol Pads Webcol Large by, Kendall Company Qty: 2 in each kit
    • 1A Mini zip lock with a toilet cover seat: The Hospeco Health Gards half-fold toilet seat cover (part number:HG-1000) which is located inside a mini zip lock. Qty:1
    • PURELL Sanitizing Hand Wipes Individually Wrapped: Qty;1 in each kit
    • Labels for patient identification
    • Instruction sheet for collection the sample
    • Requisition form for the clinicians
  • Drug Facts

  • Active ingredient

    Ethyl alcohol 62%

  • Purpose

    Antimicrobial

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Use Hand sanitizer to help reduce bacteria on the skin

  • WARNINGS

    Warnings

    • Flammable. Keep away from fire or flame,

    • For external use only

    • When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

    • Stop use and ask a doctor if irritation or rash appears and lasts

  • DOSAGE & ADMINISTRATION

    Directions • Unfold towelette; Wipe hands; Discard after use

  • Other information

    • Do not store above 110°F (43°C)
    • May discolor certain fabrics or surfaces
  • Inactive ingredients

    Water (Aqua), Isopropyl Alcohol, Acetamidopropyl Trimonium Chloride, Aloe Barbadensis Leaf Juice, C12-15 Alkyl Benzoate, Cocamidopropyl PG-Dimonium Chloride Phosphate, Glycerin, Isopropyl Myristate, Propylene Glycol, Retinyl Palmitate, Tocopheryl Acetate, Zea Mays (Corn) Oil, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Fragrance (Parfum), Methylparaben

  • Questions?

    1-800-321-9647

  • SPL UNCLASSIFIED SECTION

    PACKAGE INFORMATION

    NDC 21749-363-76

    Purell Brand®

    SANITIZING
    HAND WIPE

    Kills 99.9% of most common germs
    that may make you sick
    Not for retail sale

    ONE WIPE

    Distributed by: GOJO Industries, Inc. Akron OH 44309
    Purell is a trademark of Warner-Lambert Company LLC

  • Packaging

    lab1

  • INGREDIENTS AND APPEARANCE
    STOOL COLLECTION KIT FOR GI MOLECULAR TEST 
    container, specimen, non-sterile kit
    Product Information
    Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:70049-211
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:70049-211-701 in 1 KIT; Type 1: Convenience Kit of Co-Package
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 APPLICATOR 1.75 mL
    Part 1 of 1
    PURELL SANITIZING HAND WIPES 
    ethyl alcohol cloth
    Product Information
    Item Code (Source)NDC:21749-363
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CORN OIL (UNII: 8470G57WFM)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21749-363-761 in 1 PACKET
    11.75 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/22/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    exempt deviceNNI09/01/2015
    Labeler - H&M MEDICAL COLLECTION KITS LLC (079931322)
    Establishment
    NameAddressID/FEIBusiness Operations
    H&M MEDICAL COLLECTION KITS LLC079931322repack
    Establishment
    NameAddressID/FEIBusiness Operations
    GOJO Industries, Inc036424534manufacture
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