{
  "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": "2026-08-03",
    "results": {
      "skip": 0,
      "limit": 1,
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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": "false",
      "commercial_distribution_status": "In Commercial Distribution",
      "device_description": "Compressor Nebulizer Accessories (Tubing)",
      "public_device_record_key": "ecd3b98e-26c1-43f4-94bc-1af922549f0e",
      "has_serial_number": "false",
      "public_version_date": "2026-02-09",
      "sterilization": {
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        "is_sterilization_prior_use": "false"
      },
      "is_direct_marking_exempt": "true",
      "public_version_number": "1",
      "labeler_duns_number": "047025993",
      "is_labeled_as_no_nrl": "false",
      "identifiers": [
        {
          "id": "00810178886814",
          "type": "Primary",
          "issuing_agency": "GS1"
        }
      ],
      "is_single_use": "false",
      "is_otc": "true",
      "version_or_model_number": "LVA3077TUB",
      "has_manufacturing_date": "false",
      "brand_name": "Vive Breathe",
      "is_combination_product": "false",
      "is_kit": "false",
      "product_codes": [
        {
          "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": "K161586",
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      "device_count_in_base_package": "1",
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      "has_lot_or_batch_number": "false",
      "company_name": "VIVE HEALTH LLC",
      "public_version_status": "New",
      "has_expiration_date": "false",
      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "31309",
          "name": "Nebulizing system delivery set, single-use",
          "definition": "A collection of flexible tubing, typically non-sterile, and associated items that may include a mask or mouthpiece, a medication chamber, and connectors, used with a nebulizer to deliver an aerosol, usually medicated, to the patient's respiratory system. It is made of synthetic material and is typically a thick-walled, anti-kink tubing to prevent blockage. This is a single-use device.",
          "implantable": "false",
          "code_status": "Active"
        }
      ],
      "publish_date": "2026-01-30"
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  ]
}