{
  "format": "devicerts.device.v1",
  "cite_as": "AG Guffill, Hospitech Respiration Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/ag-guffill-bsk (data as of 2026-11-14).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/ag-guffill-bsk",
    "json_url": "https://devicerts.com/devices/ag-guffill-bsk.json",
    "markdown_url": "https://devicerts.com/devices/ag-guffill-bsk.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": "2026-11-14",
    "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/ag-guffill-bsk",
    "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": "AG Guffill",
    "registry_name": "AG GUFFILL",
    "url": "https://devicerts.com/devices/ag-guffill-bsk",
    "manufacturer": {
      "name": "Hospitech Respiration Ltd",
      "url": "https://devicerts.com/manufacturers/hospitech-respiration-ltd",
      "country": "Israel",
      "country_basis": null,
      "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": "K122721",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "BSK"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The AG Cuffill is an Inflatable Tracheal Tube Cuff, designed to measure and regulate intra-cuff pressure in endotracheal tubes, tracheotomy tubes, and laryngeal mask airways (LMAs). It ensures proper cuff inflation to maintain airway patency and reduce the risk of complications such as tracheal injury or aspiration during mechanical ventilation.\n\nThis device is intended for use in clinical settings such as hospitals, pre-hospital (EMS), and extended care facilities under medical supervision. Supplied as a reusable medical device, it is regulated under FDA 510(k) clearance (K122721) and falls under the Anesthesiology advisory committee classification. Multiple registration and FEI numbers (e.g., 3016548968, 3007048256) correspond to its various model variants, all adhering to regulation 868.5750.",
      "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": "K122721",
      "number_label": null,
      "device_udi_di": null,
      "date": "2013-05-03",
      "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": "K122721",
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            }
          ]
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        {
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        {
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            {
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            }
          ]
        },
        {
          "label": "Regulation",
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            {
              "value": "21 CFR Part 868.5750",
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            }
          ]
        },
        {
          "label": "Advisory committee",
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            {
              "value": "Anesthesiology",
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          ]
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}