{
  "format": "devicerts.device.v1",
  "cite_as": "Exactamix H938901, Baxter Healthcare Corp. deviCERTS medical device catalogue. https://devicerts.com/devices/exactamix-h938901 (data as of 2026-11-14).",
  "source": {
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    "json_url": "https://devicerts.com/devices/exactamix-h938901.json",
    "markdown_url": "https://devicerts.com/devices/exactamix-h938901.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/exactamix-h938901",
    "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": "Exactamix H938901",
    "registry_name": "EXACTAMIX H938901",
    "url": "https://devicerts.com/devices/exactamix-h938901",
    "manufacturer": {
      "name": "Baxter Healthcare Corp",
      "url": "https://devicerts.com/manufacturers/baxter-healthcare-corp",
      "country": "United States",
      "country_basis": "FDA 510(k) applicant",
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
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    },
    "classification": [
      {
        "class": "Class II",
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      }
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            ]
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      {
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        "values": [
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            "value": "00085412477466",
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          {
            "value": "K960581",
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              "FDA GUDID (AccessGUDID)"
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          }
        ]
      }
    ],
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      "KPE"
    ],
    "emdn": [],
    "gmdn": [
      {
        "code": "35127",
        "term": "Intravenous administration bag/bottle"
      }
    ],
    "description": null,
    "noindex": true
  },
  "authorizations": [
    {
      "registry": "GUDID",
      "region": "United States",
      "type": "GUDID listing",
      "number": "00085412477466",
      "number_label": "UDI-DI",
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      "date": "2016-09-23",
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      "device_udi_di": null,
      "date": "1996-04-30",
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    {
      "number": "Z-0008-2020",
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      "initiated": "2018-09-21",
      "reason": "Potential for leaking product",
      "applies": "this device",
      "via": "K960581"
    },
    {
      "number": "Z-0005-2020",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2018-09-21",
      "reason": "Potential for leaking product",
      "applies": "this device",
      "via": "K960581"
    },
    {
      "number": "Z-0001-2020",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2018-09-21",
      "reason": "Potential for leaking product",
      "applies": "this device",
      "via": "K960581"
    },
    {
      "number": "Z-0007-2020",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2018-09-21",
      "reason": "Potential for leaking product",
      "applies": "this device",
      "via": "K960581"
    },
    {
      "number": "Z-0003-2020",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2018-09-21",
      "reason": "Potential for leaking product",
      "applies": "this device",
      "via": "K960581"
    },
    {
      "number": "Z-0004-2020",
      "classification": "Class II",
      "status": "ongoing",
      "initiated": "2018-09-21",
      "reason": "Potential for leaking product",
      "applies": "this device",
      "via": "K960581"
    },
    {
      "number": "Z-0006-2020",
      "classification": "Class II",
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      "initiated": "2018-09-21",
      "reason": "Potential for leaking product",
      "applies": "this device",
      "via": "K960581"
    },
    {
      "number": "Z-2263-2016",
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      "status": "terminated",
      "initiated": "2016-06-23",
      "reason": "An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined the dispensing volume validation was not properly done and none of the compounders on the market can meet the stated specifications.",
      "applies": "shared submission",
      "via": "K960581"
    }
  ],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identity",
      "fields": [
        {
          "label": "Trade name",
          "values": [
            {
              "value": "EXACTAMIX",
              "registries": [
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              ]
            }
          ]
        },
        {
          "label": "Generic name",
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            {
              "value": "Intravenous administration bag/bottle",
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            {
              "value": "Total Volume — 1500 Milliliter",
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    {
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          "label": "Supplied sterile",
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}