{
  "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": "false",
      "is_rx": "true",
      "commercial_distribution_status": "In Commercial Distribution",
      "device_description": "Pre-pump, 8.0 mm",
      "public_device_record_key": "77af744e-7c04-4ede-a5c3-e8e9aa105b4c",
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          "type": "Package",
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          "code": "FJK",
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            "medical_specialty_description": "Gastroenterology, Urology",
            "regulation_number": "876.5820",
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      "device_count_in_base_package": "1",
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      "customer_contacts": [
        {
          "phone": "+1(800)323-5188",
          "email": "xxx@xxx.xxx"
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      "catalog_number": "03-2922-7",
      "company_name": "Fresenius Medical Care Holdings, Inc.",
      "public_version_status": "Update",
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      "gmdn_terms": [
        {
          "code": "34999",
          "name": "Haemodialysis blood tubing set, single-use",
          "definition": "A collection of tubing segments and associated devices (e.g., connectors, clamps) intended to be used to transfer blood between a patient's vascular access device and a haemodialyser during haemodialysis; it is sometimes referred to as haemodialysis blood lines. This is a single-use device.",
          "implantable": "false",
          "code_status": "Active"
        }
      ],
      "publish_date": "2015-09-24",
      "device_sizes": [
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          "type": "Total Volume",
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          "unit": "Milliliter"
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}