{
  "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": {
      "skip": 0,
      "limit": 1,
      "total": 67
    }
  },
  "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": "Not in Commercial Distribution",
      "device_description": "Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use.",
      "public_device_record_key": "2f8f9406-3f09-4f00-9c0b-41b9f54679dd",
      "has_serial_number": "false",
      "storage": [
        {
          "type": "Special Storage Condition, Specify",
          "special_conditions": "Store in a cool, dry place. Do not leave infusion sets in direct sunlight or inside a vehicle."
        }
      ],
      "public_version_date": "2024-05-10",
      "commercial_distribution_end_date": "2024-05-09",
      "sterilization": {
        "is_sterile": "true",
        "is_sterilization_prior_use": "false"
      },
      "is_direct_marking_exempt": "false",
      "public_version_number": "3",
      "labeler_duns_number": "306032491",
      "is_labeled_as_no_nrl": "false",
      "identifiers": [
        {
          "id": "05705244006539",
          "type": "Primary",
          "issuing_agency": "GS1"
        },
        {
          "id": "05705244011755",
          "type": "Unit of Use",
          "issuing_agency": "GS1"
        },
        {
          "id": "05705244006546",
          "type": "Package",
          "issuing_agency": "GS1",
          "unit_of_use_id": "05705244006539",
          "quantity_per_package": "100",
          "package_discontinue_date": "2024-05-09",
          "package_status": "Not in Commercial Distribution",
          "package_type": "Outer box"
        }
      ],
      "is_single_use": "true",
      "is_otc": "false",
      "version_or_model_number": "MMT-387",
      "has_manufacturing_date": "false",
      "brand_name": "Quick-set® Paradigm®",
      "is_combination_product": "false",
      "is_kit": "false",
      "product_codes": [
        {
          "code": "FPA",
          "name": "Set, Administration, Intravascular",
          "openfda": {
            "device_name": "Set, Administration, Intravascular",
            "medical_specialty_description": "General Hospital",
            "regulation_number": "880.5440",
            "device_class": "2"
          }
        }
      ],
      "device_count_in_base_package": "10",
      "is_pm_exempt": "false",
      "has_lot_or_batch_number": "true",
      "customer_contacts": [
        {
          "phone": "1-800-646-4633",
          "email": "xx@xx.xx"
        }
      ],
      "company_name": "Unomedical A/S",
      "public_version_status": "Update",
      "has_expiration_date": "true",
      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "35833",
          "name": "Electric infusion pump administration set, single-use",
          "definition": "A collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device.",
          "implantable": "false",
          "code_status": "Active"
        }
      ],
      "publish_date": "2016-09-15",
      "device_sizes": [
        {
          "type": "Length",
          "value": "80",
          "unit": "Centimeter"
        },
        {
          "type": "Depth",
          "value": "6",
          "unit": "Millimeter"
        },
        {
          "type": "Angle",
          "value": "90",
          "unit": "degree"
        }
      ]
    }
  ]
}