OCI
- 产品代码
- OCI
- 器械名称
- Indicator, Physical/Chemical, Storage Temperature
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 880.2800
- FDA 专业组
- General Hospital
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 可走第三方审查
- 该代码近三年的 510(k)
- 1 件
FDA 分类定义
The time-temperature indicator provides a visual signal that a selected time-temperature profile has been exceeded. When affixed to a device, a time temperature indicator is indicated, via a permanent color change, for the purpose of distinguishing between medical products that have exceeded a selected time-temperature profile of interest to the user from products that have not exceeded that profile.
FDA 官方分类页： OCI
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。