{
  "format": "devicerts.device.v1",
  "cite_as": "Arrow IPN037693, Teleflex Incorporated. deviCERTS medical device catalogue. https://devicerts.com/devices/arrow-ask-45854-pecl1 (data as of 2026-11-14).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/arrow-ask-45854-pecl1",
    "json_url": "https://devicerts.com/devices/arrow-ask-45854-pecl1.json",
    "markdown_url": "https://devicerts.com/devices/arrow-ask-45854-pecl1.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-45854-pecl1",
    "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 IPN037693",
    "registry_name": "ARROW IPN037693",
    "url": "https://devicerts.com/devices/arrow-ask-45854-pecl1",
    "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-45854-PECL1",
            "registries": [
              "FDA GUDID (AccessGUDID)"
            ]
          }
        ]
      },
      {
        "label": "Primary DI / UDI-DI",
        "values": [
          {
            "value": "10801902130423",
            "registries": [
              "FDA GUDID (AccessGUDID)"
            ]
          }
        ]
      },
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K071538",
            "registries": [
              "FDA GUDID (AccessGUDID)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "FOZ"
    ],
    "emdn": [],
    "gmdn": [
      {
        "code": "34842",
        "term": "Epidural anaesthesia set, non-medicated"
      }
    ],
    "description": null,
    "noindex": true
  },
  "authorizations": [
    {
      "registry": "GUDID",
      "region": "United States",
      "type": "GUDID listing",
      "number": "10801902130423",
      "number_label": "UDI-DI",
      "device_udi_di": null,
      "date": "2017-11-30",
      "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": "K071538",
      "number_label": null,
      "device_udi_di": null,
      "date": "2007-08-30",
      "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-2376-2026",
      "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": "shared submission",
      "via": "K071538"
    },
    {
      "number": "Z-1914-2026",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2026-03-11",
      "reason": "Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured",
      "applies": "this device",
      "via": "K071538"
    },
    {
      "number": "Z-2123-2026",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2026-01-07",
      "reason": "Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.",
      "applies": "this device",
      "via": "K071538"
    },
    {
      "number": "Z-0003-2024",
      "classification": "Class I",
      "status": "ongoing",
      "initiated": "2023-08-10",
      "reason": "This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.",
      "applies": "this device",
      "via": "K071538"
    },
    {
      "number": "Z-0002-2024",
      "classification": "Class I",
      "status": "ongoing",
      "initiated": "2023-08-10",
      "reason": "This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.",
      "applies": "this device",
      "via": "K071538"
    },
    {
      "number": "Z-0352-2023",
      "classification": "Class I",
      "status": "terminated",
      "initiated": "2022-10-27",
      "reason": "There is the potential for inadequate connection between the top and bottom housings of the Micro Clave Clear Connectors included in the Arrow MAC Two-Lumen Central Venous Access Kit and the Arrow Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit.",
      "applies": "this device",
      "via": "K071538"
    },
    {
      "number": "Z-0351-2023",
      "classification": "Class I",
      "status": "terminated",
      "initiated": "2022-10-27",
      "reason": "There is the potential for inadequate connection between the top and bottom housings of the Micro Clave Clear Connectors included in the Arrow MAC Two-Lumen Central Venous Access Kit and the Arrow Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit.",
      "applies": "this device",
      "via": "K071538"
    },
    {
      "number": "Z-1604-2022",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2022-05-25",
      "reason": "Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.",
      "applies": "this device",
      "via": "K071538"
    },
    {
      "number": "Z-2000-2018",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2018-04-11",
      "reason": "Product sterility may be compromised due to unsealed packaging.",
      "applies": "this device",
      "via": "K071538"
    },
    {
      "number": "Z-1994-2018",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2018-04-11",
      "reason": "Product sterility may be compromised due to unsealed packaging.",
      "applies": "this device",
      "via": "K071538"
    },
    {
      "number": "Z-1997-2018",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2018-04-11",
      "reason": "Product sterility may be compromised due to unsealed packaging.",
      "applies": "this device",
      "via": "K071538"
    },
    {
      "number": "Z-1995-2018",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2018-04-11",
      "reason": "Product sterility may be compromised due to unsealed packaging.",
      "applies": "this device",
      "via": "K071538"
    },
    {
      "number": "Z-1987-2018",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2018-04-11",
      "reason": "Product sterility may be compromised due to unsealed packaging.",
      "applies": "this device",
      "via": "K071538"
    },
    {
      "number": "Z-1991-2018",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2018-04-11",
      "reason": "Product sterility may be compromised due to unsealed packaging.",
      "applies": "this device",
      "via": "K071538"
    },
    {
      "number": "Z-1993-2018",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2018-04-11",
      "reason": "Product sterility may be compromised due to unsealed packaging.",
      "applies": "this device",
      "via": "K071538"
    },
    {
      "number": "Z-1992-2018",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2018-04-11",
      "reason": "Product sterility may be compromised due to unsealed packaging.",
      "applies": "this device",
      "via": "K071538"
    },
    {
      "number": "Z-1996-2018",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2018-04-11",
      "reason": "Product sterility may be compromised due to unsealed packaging.",
      "applies": "this device",
      "via": "K071538"
    },
    {
      "number": "Z-1990-2018",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2018-04-11",
      "reason": "Product sterility may be compromised due to unsealed packaging.",
      "applies": "this device",
      "via": "K071538"
    },
    {
      "number": "Z-1980-2018",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2018-04-11",
      "reason": "Product sterility may be compromised due to unsealed packaging.",
      "applies": "this device",
      "via": "K071538"
    },
    {
      "number": "Z-1981-2018",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2018-04-11",
      "reason": "Product sterility may be compromised due to unsealed packaging.",
      "applies": "this device",
      "via": "K071538"
    },
    {
      "number": "Z-1988-2018",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2018-04-11",
      "reason": "Product sterility may be compromised due to unsealed packaging.",
      "applies": "this device",
      "via": "K071538"
    },
    {
      "number": "Z-1998-2018",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2018-04-11",
      "reason": "Product sterility may be compromised due to unsealed packaging.",
      "applies": "this device",
      "via": "K071538"
    },
    {
      "number": "Z-1989-2018",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2018-04-11",
      "reason": "Product sterility may be compromised due to unsealed packaging.",
      "applies": "this device",
      "via": "K071538"
    },
    {
      "number": "Z-1999-2018",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2018-04-11",
      "reason": "Product sterility may be compromised due to unsealed packaging.",
      "applies": "this device",
      "via": "K071538"
    },
    {
      "number": "Z-1979-2018",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2018-04-11",
      "reason": "Product sterility may be compromised due to unsealed packaging.",
      "applies": "this device",
      "via": "K071538"
    },
    {
      "number": "Z-1326-2018",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2017-12-22",
      "reason": "Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.",
      "applies": "this device",
      "via": "K071538"
    },
    {
      "number": "Z-0995-2018",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2017-11-27",
      "reason": "Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.",
      "applies": "this device",
      "via": "K071538"
    },
    {
      "number": "Z-0998-2018",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2017-11-27",
      "reason": "Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.",
      "applies": "this device",
      "via": "K071538"
    },
    {
      "number": "Z-1005-2018",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2017-11-27",
      "reason": "Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.",
      "applies": "this device",
      "via": "K071538"
    },
    {
      "number": "Z-0997-2018",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2017-11-27",
      "reason": "Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.",
      "applies": "this device",
      "via": "K071538"
    },
    {
      "number": "Z-0994-2018",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2017-11-27",
      "reason": "Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.",
      "applies": "this device",
      "via": "K071538"
    },
    {
      "number": "Z-1004-2018",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2017-11-27",
      "reason": "Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.",
      "applies": "this device",
      "via": "K071538"
    },
    {
      "number": "Z-1003-2018",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2017-11-27",
      "reason": "Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.",
      "applies": "this device",
      "via": "K071538"
    },
    {
      "number": "Z-0999-2018",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2017-11-27",
      "reason": "Some of the products listed in the recall may be missing a sticker that contains the lot number, expiration date, and Unique Device Identification (UDI) information.",
      "applies": "this device",
      "via": "K071538"
    },
    {
      "number": "Z-1163-2018",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2017-11-14",
      "reason": "Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions.",
      "applies": "this device",
      "via": "K071538"
    },
    {
      "number": "Z-1162-2018",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2017-11-14",
      "reason": "Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions.",
      "applies": "this device",
      "via": "K071538"
    },
    {
      "number": "Z-1164-2018",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2017-11-14",
      "reason": "Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions.",
      "applies": "this device",
      "via": "K071538"
    },
    {
      "number": "Z-1166-2018",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2017-11-14",
      "reason": "Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions.",
      "applies": "this device",
      "via": "K071538"
    },
    {
      "number": "Z-1159-2018",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2017-11-14",
      "reason": "Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions.",
      "applies": "this device",
      "via": "K071538"
    },
    {
      "number": "Z-1161-2018",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2017-11-14",
      "reason": "Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions.",
      "applies": "this device",
      "via": "K071538"
    },
    {
      "number": "Z-1165-2018",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2017-11-14",
      "reason": "Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions.",
      "applies": "this device",
      "via": "K071538"
    },
    {
      "number": "Z-0651-2018",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2017-10-17",
      "reason": "These finished good kits may contain the incorrect Springwire Guide (SWG).",
      "applies": "this device",
      "via": "K071538"
    },
    {
      "number": "Z-0655-2018",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2017-10-17",
      "reason": "These finished good kits may contain the incorrect Springwire Guide (SWG).",
      "applies": "this device",
      "via": "K071538"
    },
    {
      "number": "Z-0649-2018",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2017-10-17",
      "reason": "These finished good kits may contain the incorrect Springwire Guide (SWG).",
      "applies": "this device",
      "via": "K071538"
    },
    {
      "number": "Z-0653-2018",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2017-10-17",
      "reason": "These finished good kits may contain the incorrect Springwire Guide (SWG).",
      "applies": "this device",
      "via": "K071538"
    },
    {
      "number": "Z-0647-2018",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2017-10-17",
      "reason": "These finished good kits may contain the incorrect Springwire Guide (SWG).",
      "applies": "this device",
      "via": "K071538"
    },
    {
      "number": "Z-2330-2017",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2017-05-09",
      "reason": "Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.",
      "applies": "this device",
      "via": "K071538"
    },
    {
      "number": "Z-1879-2017",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2017-03-17",
      "reason": "Arrow International is recalling due to possible voids in the catheter hub, which could lead to an interlumen crossover.",
      "applies": "this device",
      "via": "K071538"
    },
    {
      "number": "Z-2136-2016",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2016-06-02",
      "reason": "Arrow is recalling these products due to the possibility that although the kit is labeled as containing a 20 cm catheter, a 16 cm catheter may be packaged in the kit.",
      "applies": "this device",
      "via": "K071538"
    },
    {
      "number": "Z-1082-2015",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2015-01-02",
      "reason": "Foreign material found within the kits. The foreign material, white or black particles and/or thread, is  visible and can beidentified by the user.",
      "applies": "this device",
      "via": "K071538"
    },
    {
      "number": "Z-1005-2015",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2014-12-16",
      "reason": "the Instructions for Use (IFU) were inadvertently removed from the kit.",
      "applies": "this device",
      "via": "K071538"
    },
    {
      "number": "Z-1633-2014",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2013-07-17",
      "reason": "The labeling states that the kit contains Introducer Needle: Echogenic 18 Ga. x 2.5  (6.35cm) XTW and 5mL ArroW Raulerson Spring-Wire Introduction Syringe; however, the kit contains, and should state, Introducer Needle: 18 Ga. x 2.5  (6.35cm) XTW and 5mL ArroW Raulerson Spring-Wire Introduction Syringe. As a result of this labeling inconsistency, if the clinician were to place the needle under x-r",
      "applies": "this device",
      "via": "K071538"
    },
    {
      "number": "Z-1823-2012",
      "classification": "Class II",
      "status": "terminated",
      "initiated": "2012-06-07",
      "reason": "Arrow is recalling the product due to the possibility of voids in the catheter hub which could lead to an interlumen crossover.",
      "applies": "this device",
      "via": "K071538"
    },
    {
      "number": "Z-2491-2010",
      "classification": "",
      "status": "terminated",
      "initiated": "2010-07-29",
      "reason": "Incorrectly assembled 18 Ga x 2 1/2 Introducer Needle",
      "applies": "this device",
      "via": "K071538"
    }
  ],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identity",
      "fields": [
        {
          "label": "Trade name",
          "values": [
            {
              "value": "ARROW",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Generic name",
          "values": [
            {
              "value": "Epidural anaesthesia set, non-medicated",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Model / Ref / Catalog",
          "values": [
            {
              "value": "IPN037693",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            },
            {
              "value": "ASK-45854-PECL1",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Identifiers",
      "fields": [
        {
          "label": "Primary DI / UDI-DI",
          "values": [
            {
              "value": "10801902130423",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "510(k) Number",
          "values": [
            {
              "value": "K071538",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "FOZ",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "GMDN term",
          "values": [
            {
              "value": "Epidural anaesthesia set, non-medicated",
              "code": "34842",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
          "values": [
            {
              "value": "Class II",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Regulation number",
          "values": [
            {
              "value": "880.5200",
              "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": "Manufacturing 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)"
              ]
            }
          ]
        }
      ]
    }
  ]
}