{
  "format": "devicerts.device.v1",
  "cite_as": "V-Bag Blood Reservoir, Circulatory Technology, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/the-v-bag-dtn (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/the-v-bag-dtn",
    "json_url": "https://devicerts.com/devices/the-v-bag-dtn.json",
    "markdown_url": "https://devicerts.com/devices/the-v-bag-dtn.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      }
    ],
    "registry_records_last_synced": "2026-10-22",
    "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/the-v-bag-dtn",
    "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": "V-Bag Blood Reservoir",
    "registry_name": "THE V-BAG",
    "url": "https://devicerts.com/devices/the-v-bag-dtn",
    "manufacturer": {
      "name": "Circulatory Technology, Inc.",
      "url": "https://devicerts.com/manufacturers/circulatory-technology-inc",
      "country": "United States",
      "country_basis": "FDA 510(k) applicant",
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K001822",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "DTN"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The V-Bag is a Blood, Cardiopulmonary Bypass Reservoir (DTN), designed as a soft-shell venous reservoir for use in extracorporeal circulation during cardiovascular procedures. It collects and temporarily stores venous and cardiotomy blood, facilitating efficient drainage and minimizing air entrainment during surgical support.\n\nSupplied as a single-use, sterile disposable, the V-Bag is intended for use in controlled clinical settings such as operating rooms or cardiac catheterization labs. It is classified as a Class II device under FDA regulations (870.4400) and holds a FDA 510(k) clearance (K001822) for substantial equivalence in cardiovascular applications. No MRI safety or reusable specifications are indicated.",
      "ai_generated": true,
      "generated_on": "2026-10-01",
      "note": "Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record."
    },
    "noindex": false
  },
  "authorizations": [
    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K001822",
      "number_label": null,
      "device_udi_di": null,
      "date": "2000-07-07",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identifiers",
      "fields": [
        {
          "label": "510(k) Number",
          "values": [
            {
              "value": "K001822",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "DTN",
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            }
          ]
        }
      ]
    },
    {
      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
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            {
              "value": "Class II",
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              ]
            }
          ]
        },
        {
          "label": "Regulation",
          "values": [
            {
              "value": "21 CFR Part 870.4400",
              "registries": [
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            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "Cardiovascular",
              "registries": [
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            }
          ]
        },
        {
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          "values": [
            {
              "value": "SESE",
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            }
          ]
        }
      ]
    }
  ]
}