{
  "format": "devicerts.device.v1",
  "cite_as": "DiamondTemp™ Irrigation Pump CEDTP100, Medtronic, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/diamondtemp-irrigation-pump-cedtp100 (data as of 2026-11-14).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/diamondtemp-irrigation-pump-cedtp100",
    "json_url": "https://devicerts.com/devices/diamondtemp-irrigation-pump-cedtp100.json",
    "markdown_url": "https://devicerts.com/devices/diamondtemp-irrigation-pump-cedtp100.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/diamondtemp-irrigation-pump-cedtp100",
    "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": "DiamondTemp™ Irrigation Pump CEDTP100",
    "registry_name": "DiamondTemp™ Irrigation Pump CEDTP100",
    "url": "https://devicerts.com/devices/diamondtemp-irrigation-pump-cedtp100",
    "manufacturer": {
      "name": "Medtronic, Inc.",
      "url": "https://devicerts.com/manufacturers/medtronic-inc",
      "country": "United States",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
        "class": "Class III",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "Primary DI / UDI-DI",
        "values": [
          {
            "value": "00763000482145",
            "registries": [
              "FDA GUDID (AccessGUDID)"
            ]
          }
        ]
      },
      {
        "label": "PMA number",
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          {
            "value": "P200028",
            "registries": [
              "FDA GUDID (AccessGUDID)"
            ]
          }
        ]
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    ],
    "product_codes": [
      "OAE"
    ],
    "emdn": [],
    "gmdn": [
      {
        "code": "36664",
        "term": "Basic roller pump"
      }
    ],
    "description": null,
    "noindex": true
  },
  "authorizations": [
    {
      "registry": "GUDID",
      "region": "United States",
      "type": "GUDID listing",
      "number": "00763000482145",
      "number_label": "UDI-DI",
      "device_udi_di": null,
      "date": "2021-10-23",
      "date_kind": "listed",
      "decision_code": null,
      "expires": null,
      "withdrawn": null,
      "status": "Listed",
      "status_note": "GUDID: in commercial distribution",
      "derived_from_gudid": false
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    {
      "registry": "GUDID",
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      "type": "FDA PMA",
      "number": "P200028",
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      "device_udi_di": null,
      "date": "2021-01-28",
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    }
  ],
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      "reason": "It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the catheter.  This could result in blood stagnation, clots or air emboli.",
      "applies": "this device",
      "via": "P200028"
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    {
      "number": "Z-1318-2021",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2021-02-22",
      "reason": "It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the catheter.  This could result in blood stagnation, clots or air emboli.",
      "applies": "this device",
      "via": "P200028"
    },
    {
      "number": "Z-1317-2021",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2021-02-22",
      "reason": "It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the catheter.  This could result in blood stagnation, clots or air emboli.",
      "applies": "this device",
      "via": "P200028"
    },
    {
      "number": "Z-1322-2021",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2021-02-22",
      "reason": "It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the catheter.  This could result in blood stagnation, clots or air emboli.",
      "applies": "this device",
      "via": "P200028"
    },
    {
      "number": "Z-1319-2021",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2021-02-22",
      "reason": "It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the catheter.  This could result in blood stagnation, clots or air emboli.",
      "applies": "this device",
      "via": "P200028"
    },
    {
      "number": "Z-1321-2021",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2021-02-22",
      "reason": "It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the catheter.  This could result in blood stagnation, clots or air emboli.",
      "applies": "this device",
      "via": "P200028"
    }
  ],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identity",
      "fields": [
        {
          "label": "Trade name",
          "values": [
            {
              "value": "DiamondTemp™ Irrigation Pump",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Generic name",
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            {
              "value": "Basic roller pump",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Model / reference",
          "values": [
            {
              "value": "CEDTP100",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Identifiers",
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          "label": "Primary DI / UDI-DI",
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          ]
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        {
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            }
          ]
        },
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        }
      ]
    },
    {
      "group": "Classification",
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        {
          "label": "Device class",
          "values": [
            {
              "value": "Class III",
              "registries": [
                "FDA GUDID (AccessGUDID)"
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            }
          ]
        },
        {
          "label": "GUDID distribution status",
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            {
              "value": "In Commercial Distribution",
              "registries": [
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            }
          ]
        }
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          "label": "Prescription use",
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          "label": "Serial number",
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          "label": "Supplied sterile",
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          ]
        },
        {
          "label": "Sterilise before use",
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            {
              "value": "No",
              "registries": [
                "FDA GUDID (AccessGUDID)"
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            }
          ]
        },
        {
          "label": "Single use",
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            {
              "value": "No",
              "registries": [
                "FDA GUDID (AccessGUDID)"
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          ]
        },
        {
          "label": "Implantable",
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              "value": "No",
              "registries": [
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            }
          ]
        },
        {
          "label": "Contains latex",
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            {
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              "registries": [
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              ]
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          ]
        },
        {
          "label": "Over-the-counter",
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              "value": "No",
              "registries": [
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          ]
        },
        {
          "label": "Convenience kit",
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            {
              "value": "No",
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          ]
        },
        {
          "label": "Combination product",
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            {
              "value": "No",
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                "FDA GUDID (AccessGUDID)"
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          ]
        },
        {
          "label": "HCT/P",
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            {
              "value": "No",
              "registries": [
                "FDA GUDID (AccessGUDID)"
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          ]
        },
        {
          "label": "Premarket exempt",
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            {
              "value": "No",
              "registries": [
                "FDA GUDID (AccessGUDID)"
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            }
          ]
        },
        {
          "label": "Lot / batch number",
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            {
              "value": "No",
              "registries": [
                "FDA GUDID (AccessGUDID)"
              ]
            }
          ]
        },
        {
          "label": "Expiration date",
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            {
              "value": "No",
              "registries": [
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          ]
        },
        {
          "label": "Manufacturing date",
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              "registries": [
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            }
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}