{
  "format": "devicerts.device.v1",
  "cite_as": "Arrow IPN037402, Teleflex Incorporated. deviCERTS medical device catalogue. https://devicerts.com/devices/arrow-ask-19608-cc-197aa20d (data as of 2026-11-14).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/arrow-ask-19608-cc-197aa20d",
    "json_url": "https://devicerts.com/devices/arrow-ask-19608-cc-197aa20d.json",
    "markdown_url": "https://devicerts.com/devices/arrow-ask-19608-cc-197aa20d.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": "2026-11-14",
    "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/arrow-ask-19608-cc-197aa20d",
    "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": "Arrow IPN037402",
    "registry_name": "ARROW IPN037402",
    "url": "https://devicerts.com/devices/arrow-ask-19608-cc-197aa20d",
    "manufacturer": {
      "name": "Teleflex Incorporated",
      "url": "https://devicerts.com/manufacturers/teleflex-incorporated",
      "country": null,
      "country_basis": null,
      "fda_registration_country": "United States"
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "Catalogue number",
        "values": [
          {
            "value": "ASK-19608-CC",
            "registries": [
              "FDA GUDID (AccessGUDID)"
            ]
          }
        ]
      },
      {
        "label": "Primary DI / UDI-DI",
        "values": [
          {
            "value": "10801902125092",
            "registries": [
              "FDA GUDID (AccessGUDID)"
            ]
          }
        ]
      },
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K121403",
            "registries": [
              "FDA GUDID (AccessGUDID)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "CAZ"
    ],
    "emdn": [],
    "gmdn": [
      {
        "code": "46383",
        "term": "Peripheral anaesthesia catheter set, non-medicated"
      }
    ],
    "description": null,
    "noindex": true
  },
  "authorizations": [
    {
      "registry": "GUDID",
      "region": "United States",
      "type": "GUDID listing",
      "number": "10801902125092",
      "number_label": "UDI-DI",
      "device_udi_di": null,
      "date": "2016-09-30",
      "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": "K121403",
      "number_label": null,
      "device_udi_di": null,
      "date": "2012-06-20",
      "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-2364-2026",
      "classification": "Class I",
      "status": "ongoing",
      "initiated": "2026-04-21",
      "reason": "Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.",
      "applies": "this device",
      "via": "K121403"
    },
    {
      "number": "Z-1253-2020",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2019-12-20",
      "reason": "Product lidstock contains the incorrect expiration date for the product",
      "applies": "this device",
      "via": "K121403"
    },
    {
      "number": "Z-1241-2020",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2019-12-20",
      "reason": "Product lidstock contains the incorrect expiration date for the product",
      "applies": "this device",
      "via": "K121403"
    },
    {
      "number": "Z-1239-2020",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2019-12-20",
      "reason": "Product lidstock contains the incorrect expiration date for the product",
      "applies": "this device",
      "via": "K121403"
    },
    {
      "number": "Z-1958-2018",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2018-04-11",
      "reason": "Product sterility may be compromised due to unsealed packaging.",
      "applies": "this device",
      "via": "K121403"
    },
    {
      "number": "Z-0573-2015",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2014-11-10",
      "reason": "Arrow is recalling certain lots of the Continuous\nNerve Block Component, Product Code: AB-18040-N,\ndue to a labeling inconsistency. The product\nlidstock incorrectly identifies the needle in the finished good as 17Ga rather than the correct 18Ga. The product\nincluded in the package is the correct 18Ga size. No injuries or illnesses have been reported.",
      "applies": "this device",
      "via": "K121403"
    },
    {
      "number": "Z-0546-2014",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2013-10-09",
      "reason": "A labeling inconsistency was discovered in which the lidstock states that the kit contains a stimulator cable with 1.5mm socket, however, the kit contains a stimulator cable with 1.5mm pin.",
      "applies": "this device",
      "via": "K121403"
    }
  ],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identity",
      "fields": [
        {
          "label": "Trade name",
          "values": [
            {
              "value": "ARROW",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Generic name",
          "values": [
            {
              "value": "Peripheral anaesthesia catheter set, non-medicated",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Model / Ref / Catalog",
          "values": [
            {
              "value": "IPN037402",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            },
            {
              "value": "ASK-19608-CC",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Identifiers",
      "fields": [
        {
          "label": "Primary DI / UDI-DI",
          "values": [
            {
              "value": "10801902125092",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "510(k) Number",
          "values": [
            {
              "value": "K121403",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "CAZ",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "GMDN term",
          "values": [
            {
              "value": "Peripheral anaesthesia catheter set, non-medicated",
              "code": "46383",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
          "values": [
            {
              "value": "Class II",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Regulation number",
          "values": [
            {
              "value": "868.5140",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "GUDID distribution status",
          "values": [
            {
              "value": "In Commercial Distribution",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Properties",
      "fields": [
        {
          "label": "Supplied sterile",
          "values": [
            {
              "value": "Yes",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Single use",
          "values": [
            {
              "value": "Yes",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Prescription use",
          "values": [
            {
              "value": "Yes",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Convenience kit",
          "values": [
            {
              "value": "Yes",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Combination product",
          "values": [
            {
              "value": "Yes",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Lot / batch number",
          "values": [
            {
              "value": "Yes",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Expiration date",
          "values": [
            {
              "value": "Yes",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Sterilise before use",
          "values": [
            {
              "value": "No",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Implantable",
          "values": [
            {
              "value": "No",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Contains latex",
          "values": [
            {
              "value": "No",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Over-the-counter",
          "values": [
            {
              "value": "No",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "HCT/P",
          "values": [
            {
              "value": "No",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Premarket exempt",
          "values": [
            {
              "value": "No",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Serial number",
          "values": [
            {
              "value": "No",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Manufacturing date",
          "values": [
            {
              "value": "No",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        }
      ]
    }
  ]
}