{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-10-01",
    "results": {
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  "results": [
    {
      "has_donation_id_number": "false",
      "mri_safety": "Labeling does not contain MRI Safety Information",
      "record_status": "Published",
      "is_labeled_as_nrl": "true",
      "is_rx": "true",
      "commercial_distribution_status": "In Commercial Distribution",
      "device_description": "Bardex® Lubricath® Foley Catheter Whistle Tip 3 Way Continuous Irrigation  5cc Balloon Lubricious Coated",
      "public_device_record_key": "867f6e8e-c360-4efa-a40e-c32a922f6d1f",
      "has_serial_number": "false",
      "public_version_date": "2020-12-04",
      "sterilization": {
        "is_sterile": "true",
        "is_sterilization_prior_use": "false"
      },
      "is_direct_marking_exempt": "false",
      "public_version_number": "8",
      "labeler_duns_number": "016898496",
      "is_labeled_as_no_nrl": "false",
      "identifiers": [
        {
          "id": "10801741018920",
          "type": "Package",
          "issuing_agency": "GS1",
          "unit_of_use_id": "00801741018923",
          "quantity_per_package": "12",
          "package_status": "In Commercial Distribution",
          "package_type": "CA"
        },
        {
          "id": "00801741018923",
          "type": "Primary",
          "issuing_agency": "GS1"
        }
      ],
      "is_single_use": "true",
      "is_otc": "false",
      "version_or_model_number": "0132L22",
      "has_manufacturing_date": "false",
      "brand_name": "Bardex® Lubricath® Foley Catheter Whistle Tip",
      "is_combination_product": "false",
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      "product_codes": [
        {
          "code": "EZC",
          "name": "CATHETER, COUDE",
          "openfda": {
            "device_name": "Catheter, Coude",
            "medical_specialty_description": "Gastroenterology, Urology",
            "regulation_number": "876.5130",
            "device_class": "2"
          }
        }
      ],
      "device_count_in_base_package": "1",
      "is_pm_exempt": "false",
      "has_lot_or_batch_number": "true",
      "customer_contacts": [
        {
          "phone": "+1(800)526-4455",
          "email": "medical.services@crbard.com"
        }
      ],
      "catalog_number": "0132L22",
      "company_name": "C. R. Bard, Inc.",
      "public_version_status": "Update",
      "has_expiration_date": "true",
      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "34917",
          "name": "Indwelling urethral drainage balloon catheter, non-antimicrobial",
          "definition": "A flexible tube with an inflatable balloon at its distal tip intended to be inserted through the urethra and retained in the urinary bladder, or prostatic bed, of an adult or paediatric patient to function as an indwelling therapeutic device for urinary drainage; it might also be designed for infusion of fluids (irrigation). It may have a bent tip (coude) to facilitate insertion, and some types may be provided with a guidewire to facilitate difficult insertion (e.g., in cases of enlarged prostate); it does not include an antimicrobial agent(s). Most types are commonly known as a Foley catheter; it is intended to be introduced by a healthcare professional. This is a single-use device.",
          "implantable": "false",
          "code_status": "Active"
        }
      ],
      "publish_date": "2016-06-02",
      "device_sizes": [
        {
          "type": "Catheter Gauge",
          "value": "22",
          "unit": "French"
        }
      ]
    }
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}