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医疗器械 · FDA 器械监管分类(非厂家操作说明书)

Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation

Normothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To Transplantation

Product code QBA · Class 3 · Unknown

说明与适用边界

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监管定义 / Regulatory definition

To preserve donor lungs prior to transplantation

监管信息 / Regulatory information

FDA product code: QBA Device class: 3 Regulation: Not supplied Specialty: Unknown Implant flag: N Life sustaining/supporting flag: N

使用说明核对

该条目描述监管产品类别,不对应某个型号。实际操作须使用该厂家、型号和软件版本的说明书,核对预期用途、适应证、禁忌、校准、耗材兼容性、清洁灭菌、维护与报警处理。类别资料不能替代厂家使用说明。

来源、版本与许可

资料类型
FDA 器械监管分类(非厂家操作说明书)
版本
2026-10-08
获取时间
2026-10-08
许可
openFDA public data; retain original label attribution. See 查看来源 and dataset source notices. Public access does not imply approval or unrestricted rights to every submitted label.
核对原始来源