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510(k) Data Aggregation
K Number
K203431Device Name
Disposable Ear Thermometer Probe Cover
Manufacturer
Date Cleared
2021-07-28
(247 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Huaian Zhongxin Packing Material Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The probe cover is used as a sanitary barrier between the infra red thermometer and the ear canal. The probe cover is provided non-sterile and for single use only.
Device Description
The Disposable Ear Thermometer Probe Cover is a disposable plastic cover made of a biocompatible polypropylene material that is dimensionally manufactured to set tolerances so that it can be fitted on the probe tip of the thermometer. The probe cover is used as a sanitary barrier between the infra red thermometer and the ear canal to prevent any ear secretions or particulates from being transferred between different people. The subject device is used as barriers between Braun Thermoscan® PRO3000 series/PRO4000 series/PRO6000 series ear thermometer, and also compatible with Braun Thermoscan® IRT1020/IRT2020/IRT2520/IRT3020/ IRT3520/IRT4020/IRT4520/IRT6020/IRT6520 ear thermometer and users' auditory canal measuring sites to avoid possible contamination and infection during temperature measuring. The probe covers are transparent, colorless and odorless, non-sterile and intended for single use only.
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