{
  "format": "devicerts.device.v1",
  "cite_as": "Bci 1148, ICU Medical, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/bci-1148 (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/bci-1148",
    "json_url": "https://devicerts.com/devices/bci-1148.json",
    "markdown_url": "https://devicerts.com/devices/bci-1148.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA GUDID (AccessGUDID)",
        "url": "https://accessgudid.nlm.nih.gov/"
      },
      {
        "registry": "FDA recalls",
        "url": "https://open.fda.gov/apis/device/recall/"
      }
    ],
    "registry_records_last_synced": "2026-10-23",
    "status_as_of": "2026-11-15",
    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.",
    "attribution": "DevicErts, https://devicerts.com/devices/bci-1148",
    "disclaimer": "Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails."
  },
  "device": {
    "name": "Bci 1148",
    "registry_name": "BCI 1148",
    "url": "https://devicerts.com/devices/bci-1148",
    "manufacturer": {
      "name": "ICU Medical, Inc.",
      "url": "https://devicerts.com/manufacturers/icu-medical-inc",
      "country": "United States",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "Primary DI / UDI-DI",
        "values": [
          {
            "value": "35019517053641",
            "registries": [
              "FDA GUDID (AccessGUDID)"
            ]
          }
        ]
      },
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K991086",
            "registries": [
              "FDA GUDID (AccessGUDID)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "CCK"
    ],
    "emdn": [],
    "gmdn": [
      {
        "code": "16545",
        "term": "Angiography kit"
      }
    ],
    "description": null,
    "noindex": true
  },
  "authorizations": [
    {
      "registry": "GUDID",
      "region": "United States",
      "type": "GUDID listing",
      "number": "35019517053641",
      "number_label": "UDI-DI",
      "device_udi_di": null,
      "date": "2016-10-13",
      "date_kind": "listed",
      "decision_code": null,
      "expires": null,
      "withdrawn": null,
      "status": "Listed",
      "status_note": "GUDID: in commercial distribution",
      "derived_from_gudid": false
    },
    {
      "registry": "GUDID",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K991086",
      "number_label": null,
      "device_udi_di": null,
      "date": "1999-06-09",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": true
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [
    {
      "number": "Z-0920-2010",
      "classification": "",
      "status": "terminated",
      "initiated": "2010-01-15",
      "reason": "Smiths Medical is conducting a voluntary recall of a limited number of medical device AC power cords, manufactured by Electri-Cord Manufacturing Co., for use with BCI 3180 Pulse Oximeter(Human), 9200 Advisor Vital Signs Monitor(Human or Veterinary), 8400 Capnocheck II Capnometer(Human or Veterinary)  and V6400 Invasive Pressure Monitor (Veterinary).\nThe affected Electri-Cord AC power cords are eq",
      "applies": "this device",
      "via": "K991086"
    }
  ],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identity",
      "fields": [
        {
          "label": "Trade name",
          "values": [
            {
              "value": "BCI",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Generic name",
          "values": [
            {
              "value": "Angiography kit",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Model / reference",
          "values": [
            {
              "value": "1148",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Identifiers",
      "fields": [
        {
          "label": "Primary DI / UDI-DI",
          "values": [
            {
              "value": "35019517053641",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "510(k) Number",
          "values": [
            {
              "value": "K991086",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "CCK",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "GMDN term",
          "values": [
            {
              "value": "Angiography kit",
              "code": "16545",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
          "values": [
            {
              "value": "Class II",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Regulation number",
          "values": [
            {
              "value": "868.1400",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "GUDID distribution status",
          "values": [
            {
              "value": "In Commercial Distribution",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Properties",
      "fields": [
        {
          "label": "Single use",
          "values": [
            {
              "value": "Yes",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Prescription use",
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            {
              "value": "Yes",
              "registries": [
                "FDA GUDID (AccessGUDID)"
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            }
          ]
        },
        {
          "label": "Lot / batch number",
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            {
              "value": "Yes",
              "registries": [
                "FDA GUDID (AccessGUDID)"
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          ]
        },
        {
          "label": "Supplied sterile",
          "values": [
            {
              "value": "No",
              "registries": [
                "FDA GUDID (AccessGUDID)"
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            }
          ]
        },
        {
          "label": "Sterilise before use",
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            {
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              "registries": [
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            }
          ]
        },
        {
          "label": "Implantable",
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            {
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              "registries": [
                "FDA GUDID (AccessGUDID)"
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            }
          ]
        },
        {
          "label": "Contains latex",
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            {
              "value": "No",
              "registries": [
                "FDA GUDID (AccessGUDID)"
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            }
          ]
        },
        {
          "label": "Over-the-counter",
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            {
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              "registries": [
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            }
          ]
        },
        {
          "label": "Convenience kit",
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            {
              "value": "No",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Combination product",
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            {
              "value": "No",
              "registries": [
                "FDA GUDID (AccessGUDID)"
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            }
          ]
        },
        {
          "label": "HCT/P",
          "values": [
            {
              "value": "No",
              "registries": [
                "FDA GUDID (AccessGUDID)"
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          ]
        },
        {
          "label": "Premarket exempt",
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            {
              "value": "No",
              "registries": [
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              ]
            }
          ]
        },
        {
          "label": "Serial number",
          "values": [
            {
              "value": "No",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Expiration date",
          "values": [
            {
              "value": "No",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Manufacturing date",
          "values": [
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              "registries": [
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              ]
            }
          ]
        }
      ]
    }
  ]
}