{
  "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",
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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": "Penguin Compressor Nebulizer",
      "public_device_record_key": "26fae46a-adfe-4add-ae50-b1ca24d3e279",
      "has_serial_number": "true",
      "public_version_date": "2025-09-24",
      "sterilization": {
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        "is_sterilization_prior_use": "false"
      },
      "is_direct_marking_exempt": "false",
      "public_version_number": "7",
      "labeler_duns_number": "867673159",
      "is_labeled_as_no_nrl": "false",
      "identifiers": [
        {
          "id": "10822383579181",
          "type": "Package",
          "issuing_agency": "GS1",
          "unit_of_use_id": "00822383579184",
          "quantity_per_package": "6",
          "package_status": "In Commercial Distribution"
        },
        {
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      ],
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      "version_or_model_number": "MQ6002",
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        {
          "code": "BTI",
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            "device_class": "2"
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        },
        {
          "code": "CAF",
          "name": "NEBULIZER (DIRECT PATIENT INTERFACE)",
          "openfda": {
            "device_name": "Nebulizer (Direct Patient Interface)",
            "medical_specialty_description": "Anesthesiology",
            "regulation_number": "868.5630",
            "device_class": "2"
          }
        }
      ],
      "premarket_submissions": [
        {
          "submission_number": "K031413",
          "supplement_number": "000"
        }
      ],
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      "company_name": "Drive Devilbiss Healthcare",
      "public_version_status": "Update",
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      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "35457",
          "name": "Therapeutic agent nebulizer, benchtop",
          "definition": "An assembly of devices intended to be used in the home and clinical to aerosolize medication/fluids, by non-heat-dependent means (i.e., not a vaporizer), for inhalation by a patient, typically to treat/manage a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It includes an electrically-powered generator (ultrasonic and/or compressor jet type), a reservoir, and a nebulizing chamber where the nebulization of the medicine usually occurs. Disposable devices (e.g., tubing, mask, mouthpiece) are attached to the device for inhalation. It is designed to be placed on a benchtop/flat surface during use.",
          "implantable": "false",
          "code_status": "Active"
        }
      ],
      "publish_date": "2016-09-16"
    }
  ]
}