{
  "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,
      "total": 1
    }
  },
  "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": "Homedics pulse oximeter",
      "public_device_record_key": "f4972d76-cf93-45fb-a051-fd98916ece6b",
      "has_serial_number": "true",
      "public_version_date": "2026-04-30",
      "sterilization": {
        "is_sterile": "false",
        "is_sterilization_prior_use": "false"
      },
      "is_direct_marking_exempt": "false",
      "public_version_number": "1",
      "labeler_duns_number": "527098717",
      "is_labeled_as_no_nrl": "false",
      "identifiers": [
        {
          "id": "06938395500307",
          "type": "Primary",
          "issuing_agency": "GS1"
        }
      ],
      "is_single_use": "false",
      "is_otc": "true",
      "version_or_model_number": "PX-250HCO",
      "has_manufacturing_date": "true",
      "brand_name": "Homedics",
      "is_combination_product": "false",
      "is_kit": "false",
      "product_codes": [
        {
          "code": "PGJ",
          "name": "Oximeter, Wellness",
          "openfda": {
            "device_name": "Oximeter, Wellness",
            "medical_specialty_description": "Cardiovascular",
            "regulation_number": "870.2700",
            "device_class": "2"
          }
        }
      ],
      "device_count_in_base_package": "1",
      "is_pm_exempt": "false",
      "has_lot_or_batch_number": "true",
      "company_name": "Shenzhen Hexin ZONDAN Medical Equipment Co., Ltd",
      "public_version_status": "New",
      "has_expiration_date": "false",
      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "45607",
          "name": "Pulse oximeter",
          "definition": "An electrically-powered photoelectric device designed for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals are produced by light-emitting diodes (LEDs) and received by a photodetector. The device displays the SpO2 values and may also measure/display pulse rate. It is typically applied to the fingertip or around the wrist, may be single-component (with built-in probe) or multi-component (includes external probe), and may in addition wirelessly transmit measurements to a receiving location (e.g., central station, bedside monitor); it is intended to be operated by laypersons and healthcare providers.",
          "implantable": "false",
          "code_status": "Active"
        }
      ],
      "publish_date": "2026-04-22"
    }
  ]
}