{
  "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": "ROSCOE FINGERTIP PULSE OXIMETER, INCLUDES LANYARD AND 2 AAA BATTERIES",
      "public_device_record_key": "0d20ac47-caba-414e-9626-693e67da1836",
      "has_serial_number": "true",
      "public_version_date": "2026-01-27",
      "sterilization": {
        "is_sterile": "false",
        "is_sterilization_prior_use": "false"
      },
      "is_direct_marking_exempt": "false",
      "public_version_number": "5",
      "labeler_duns_number": "827221698",
      "is_labeled_as_no_nrl": "false",
      "identifiers": [
        {
          "id": "30092237621982",
          "type": "Package",
          "issuing_agency": "GS1",
          "unit_of_use_id": "00092237621981",
          "quantity_per_package": "200",
          "package_status": "In Commercial Distribution"
        },
        {
          "id": "00092237621981",
          "type": "Primary",
          "issuing_agency": "GS1"
        }
      ],
      "is_single_use": "false",
      "is_otc": "true",
      "version_or_model_number": "POX-ROS",
      "has_manufacturing_date": "false",
      "brand_name": "Roscoe Medical",
      "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"
          }
        },
        {
          "code": "OCH",
          "name": "Oximeter, Infrared, Sporting, Aviation",
          "openfda": {
            "device_name": "Oximeter, Infrared, Sporting, Aviation",
            "medical_specialty_description": "Cardiovascular",
            "regulation_number": "870.2700",
            "device_class": "2"
          }
        }
      ],
      "device_count_in_base_package": "1",
      "is_pm_exempt": "true",
      "has_lot_or_batch_number": "false",
      "customer_contacts": [
        {
          "phone": "800-376-7263",
          "email": "customerservice@compasshealthbrands.com"
        }
      ],
      "company_name": "COMPASS HEALTH BRANDS CORP.",
      "public_version_status": "Update",
      "has_expiration_date": "false",
      "is_hct_p": "false",
      "gmdn_terms": [
        {
          "code": "37808",
          "name": "Pulse oximeter probe, reusable",
          "definition": "A photoelectric device designed to be applied externally to a body site (e.g., fingertip, ear lobe, bridge of nose, toe, or bridge of the foot) for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using signals produced by a light-emitting diode (LED) and received by a photodetector. The signals are subsequently transmitted to an oximeter/monitor (not included) which measures and displays the SpO2. This is a reusable device.",
          "implantable": "false",
          "code_status": "Active"
        }
      ],
      "publish_date": "2019-10-01"
    }
  ]
}