{
  "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": {
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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": "Rumble Tuff Baby Nasal Aspirator",
      "public_device_record_key": "578d1942-b202-4ba9-af73-2955ad539782",
      "has_serial_number": "false",
      "public_version_date": "2025-12-11",
      "sterilization": {
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        "is_sterilization_prior_use": "false"
      },
      "is_direct_marking_exempt": "false",
      "public_version_number": "2",
      "labeler_duns_number": "782208318",
      "is_labeled_as_no_nrl": "false",
      "identifiers": [
        {
          "id": "10879388002091",
          "type": "Package",
          "issuing_agency": "GS1",
          "unit_of_use_id": "00879388002094",
          "quantity_per_package": "12",
          "package_status": "In Commercial Distribution",
          "package_type": "Inner Pack"
        },
        {
          "id": "00879388002094",
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        },
        {
          "id": "20879388002098",
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          "issuing_agency": "GS1",
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          "package_status": "In Commercial Distribution",
          "package_type": "Case"
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      ],
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      "version_or_model_number": "BN303",
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      "brand_name": "Rumble Tuff",
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      "product_codes": [
        {
          "code": "GCY",
          "name": "Apparatus, Suction, Single Patient Use, Portable, Nonpowered",
          "openfda": {
            "device_name": "Apparatus, Suction, Single Patient Use, Portable, Nonpowered",
            "medical_specialty_description": "General, Plastic Surgery",
            "regulation_number": "878.4680",
            "device_class": "1"
          }
        }
      ],
      "device_count_in_base_package": "1",
      "is_pm_exempt": "true",
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      "customer_contacts": [
        {
          "phone": "8552288388",
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      ],
      "company_name": "A Cute Baby Inc",
      "public_version_status": "Update",
      "has_expiration_date": "false",
      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "41826",
          "name": "Nasal aspirator, manual",
          "definition": "A portable, hand-held, manual suction device designed to enable an adult to gently suction and clear excessive mucus from the nasal passages of an infant or child to facilitate easier breathing. It is available in a variety of forms including a compressible bulb with a tube that is inserted into the nares, or a syringe with a small bulb at its distal end that is applied to the nasal opening. It is designed for domestic use. This is a reusable device.",
          "implantable": "false",
          "code_status": "Active"
        }
      ],
      "publish_date": "2025-12-03"
    }
  ]
}