in accordance with our privacy policies. HeTaiDa Technology was established as a design and software provider of infrared body thermometers, who is the most professional designer and manufacture for Infrared Body thermometer since 2004, We have supplied to several famous brands, such as Pfizer, Wyeth and Carrefour, the precision and stability of our products are nearly to international famous brand name BARUN and FLUK. A general knowledge of infrared thermometers and an understanding of the features and functions of the thermometer are prerequisites for proper use. GTIN. It can be used repeatedly and has an estimated life span of three (3) years. Indicates any special storage requirements for the device. 6970289038220. Phone : +27 11 475-8504 Measure the body’s temperature hassle-free without touching the forehead with a non-contact infrared thermometer. FDA Premarket submission is not required for this device. See 21 CFR 807.3(b) for exceptions. Definition of the common device type associated with the GMDN Preferred Term Code/FDA PT Code. Indicates storage and handling requirements that are required for the device including temperature, humidity, and atmospheric pressure. HTD Owner's Manuals ; Owner's Manuals. Indicates that the product is comprised of two or more regulated products that are physically, chemically, or otherwise combined or mixed and produced as a single entity; packaged together as a single package; or packaged separately for the intended use together as defined under 21 CFR 3.2(e). A … Postal Address : 1091 Gewelhuise Street, Allen’s Nek, 1709, Johannesburg, South Africa, Mail : roy@rseprojects.co.za The version or model found on the device label or accompanying packaging used to identify a category or design of a device. All registered trademarks, used in the content, are the property of their owners. HETAIDA TECHNOLOGY CO.,LTD. Page 1 MOBI QUICK START User Instructions Model HTD8813C 70113 SN2004605520228 LOT 2535 The MOBI® non-contact infrared body scan thermometer is a hand-held medical device intended for the quick measurement of body temperature (forehead) without touching the patient. He-Taida Infrared Thermometer is a device which is used to measure temperature without actually touching the forehead. Numeric value for the clinically relevant size measurement of the medical device. Find many great new & used options and get the best deals for HTD8813C Digital LCD Infrared Forehead Thermometer Non-touch Temperature Measure at the best online prices at eBay! Date: 2016-11-14: LPOW-2415B Installation Instructions. If you think somebody is violating your copyrights and want to notify us, you can find information The brand name is the name that is typically registered with USPTO and have the ® and/or TM symbol. Indicates the date the device is no longer held or offered for sale by the labeler on record. when you use our Services. Servicing and technical facilities are available with on-site or workshop repairs. Phone Extension for the Customer contact. The unit of measure associated with each clinically relevant size. Shenzhen Hetaida Technology Limited Company, Experts in Manufacturing and Exporting Infrared body thermometer,Infrared forehead thermometer and 204 more Products. Indicates the date the DI Record is published and available via Public Search. The HeTaiDa Non Contact Infrared Body Thermometers are designed to be used for intermittent measurement and monitoring of human body temperature in the home and primary care setting as a screening tool. Step 1: The default temperature unit of the infrared thermometer is Celsius ℃.The display screen also includes battery power, laser positioning information, and so on. Choosing 'Yes' indicates that the device label or packaging contains one of the following statements: (1) "Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions", (2) This Product Contains Dry Natural Rubber", (3) Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions" or (4) "The Packaging of This Product Contains Dry Natural Rubber". Indicates the method(s) of sterilization that can be used for this device prior to device use on the patient. The non contact infrared body thermometer is a medical device, and can be used repeatedly, which using life is 5 years. Find the personal care product manual that you need at ManualsOnline. We don't know when or if this item will be back in stock. The page provides a catalogue of brands and devices, each offering to view or download an updated manual. Description. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Non Contact Infrared Body Thermometer. If you have a Beurer IR thermometer or other infrared thermometer, you can perform the steps below to change the unit from Celsius to Fahrenheit. 01- Forehead Thermometer Operation Guidelines. Non-Contact Forehead IR Thermometer User Manual 9.Advice For The 1 Usest For stable and reliable results, it is essential to check the Non-contact Body Infrared Thermometer and change as needed, as follows: 1st step: take the temperature of a person using a conventional thermometer; you will get 37.5°C (99.5°F) for instance. It also helps to minimize the risks of infections and lets you measure temperature without the discomfort of having to sit still with a thermometer in the mouth, armpit, or rectum long enough to obtain a correct temperature reading. The forehead thermometer works when ambient temperature is between 5°C & 40°C & the relative humidity is less than 93%. Measure the body’s temperature hassle-free without touching the forehead with a non-contact infrared thermometer. The non contact infrared body thermometer is a medical device, and can be used repeatedly, which using life is 5 years. Shenzhen Hetaida Technology Limited Company, Experts in Manufacturing and Exporting Infrared body thermometer,Infrared forehead thermometer and 209 more Products. Indicates that the device or packaging contains natural rubber that contacts humans as described under 21 CFR 801.437. Device Name: Non Contact Infrared Body Thermometer. It uses a multi colour display to diagnose fever & is an accurate forehead thermometer. This number is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device manufacturing, packaging, labeleing, distribution and use to be determined. Additional undefined device size not represented in the GUDID Size Type LOV. General knowledge of Infrared thermometer and an understanding of the features and functions of the HTD8813 thermometer model are prerequisites for proper use. Indicates that the device requires a prescription to use. Indicates whether the package is in commercial distribution as defined under 21 CFR 807.3(b). Not all medical products that are NOT made with natural rubber latex will be marked. The date on which a device is manufactured. Copyright © 2007-2021. Date: 2020-06-15: LPA/LPA-IP User Manual 3.7. This user manual is intended to provide the necessary information for the proper operation of the model MS-131002 non-contact infrared body thermometer. Indicates the high value for storage and handling requirements. General knowledge of Infrared Thermometer and an understanding of the features Organization accredited by FDA to operate a system for the issuance of UDIs. Name of the common device type associated with the GMDN Preferred Term Code/FDA PT Code. HTD8813C Non Contact Forhead Infrared Thermometer Clinical Digital Forehead Thermometer 3 Color Back-lit LCD display,easy to read in the dark Read temperatures in 0.5 … ... HTD8813C Digital LCD Infrared Forehead Thermometer Non-touch Temperature Measure ... HeTaiDa. Indicates the date this particular package configuration is discontinued by the labeler. This number/code is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device manufacturing, packaging, labeleing, distribution and use to be determined. MOBI puts excellent innovation, design and technology together to bring smart choices to the marketplace. Thermometer, blood pressure monitor, blood glucose meter products from Shenzhen Hetaida Technology Co.,Ltd All rights reserved. Indicates whether the device is in commercial distribution as defined under 21 CFR 807.3(b). This non contact thermometer works in ambient temperatures between 5°C & 40°C & where the relative humidity is less than 93%. Please read the manual �irst before using it, if not fully understand the usages, please Date: 2016-11-14: LPOW-2460B Installation notes. Thermometer No Contact, Digital Infrared Thermometer Forehead for Adults and Kids, Medical Fever FDA Thermometer Gun w/Alarm, Upgrade Hetaida Thermometer HTD8813C, w/ … Thermometer is an essential device used in every household. This technology minimizes the risks of infections and ensures you get an accurate temperature reading every … This date is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device manufacturing, packaging, labeleing, distribution and use to be determined. We provide information to help copyright holders manage their intellectual property online. Kits are a collection of products, including medical devices, that are packaged together to achieve a common intended use and is being distributed as a medical device. Ean. Classification for devices issued by the FDA. Sold as the Mobi Non-Contact Forehead Thermometer, among other names, original equipment manufacturer Hetaida’s htd8813c is a serviceable contactless forehead thermometer. Page 1 of 1 Start over Page 1 of 1 . The date by which the label of a device states the device must or should be used. Phone number for the Customer contact; to be used by patients and consumers for device-related questions. Quality Infrared body thermometer for sale, Infrared body thermometer & Infrared forehead thermometer provided by China Suppliers - Shenzhen Hetaida Technology Limited Company. according to the process set out in the U.S. Digital Millennium Copyright Act. Pictures of the above equipment is available on request. See ISO/TS 11139. Indicates that the device is intended for one use or on a single patient during a single procedure. This section is dedicated to Thermometer manuals & user guides which are included in the main list of categories. This shopping feature will continue to load items when the Enter key is pressed. This information may 1) be on a label attached to a durable device, 2) be on a package of a disposable device, or 3) appear in labeling materials of an implantable device. We respond to notices of alleged copyright infringement and terminate accounts of repeat infringers Subscribe to Our Newsletter to get Important News and offers: Measuring distance: 1cm to 5cm from surface, Easy and fast operation, quick display of body temperature in just under 2 seconds, Green, yellow and red fever display indicator, Large LCD Screen for clear measurement results, Automatic shutdown when not in use, saving power. NOTE Please wait for more than 30 minutes after the thermometer is moved into the measurement environment. Product link (buy here): http://gbe.st/301jVnM*Earth Day SPECIAL PROMOTION!!! Customers who viewed this item also viewed. A … Personal care manuals and free healthcare pdf instructions. HeTaiDa Technology Co., Ltd. ℅ You Yijie Qimmiq Medical Consulting Service Co., Ltd. RM.1711, Building K, NO.101 Science Ave International Creative Valley, Guangzhou, 510663 CHINA Re: K180385 Trade/Device Name: Infrared Body Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer HTD8813C. HIPAA liability, trademark, document use and software licensing rules apply. The Donation Identification Number is applicable to devices that are also regulated as HCT/Ps and is a number that is assigned to each donation. Indicates that the device does not require a prescription to use and can be purchased over the counter (OTC). 2nd functions of the HTD8813 thermometer model are prerequisites for proper use. Additional relevant information about the device that is not already captured as a distinct GUDID data attribute. Version (Model) Number: HTD8813C. The Proprietary/Trade/Brand name of the medical device as used in device labeling or in the catalog. This date is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device manufacturing, packaging, labeleing, distribution and use to be determined. - 1 Non-contact Infrared Thermometer - 1 instruction manual -(The packing does not contain batteries). LOYTEC Device User Manual 7.2. The device may or may not still be available for purchase in the marketplace. Dimension type for the clinically relevant measurement of the medical device. Currently unavailable. This number is required to be part of the UDI when included on the label in order to provide the means to track the device back to its manufacturing source or otherwise allow the history of the device manufacturing, packaging, labeleing, distribution and use to be determined. Hetaida Non Contact Infared Body Thermometer HTD8813c Brand: HeTaiDa. 4.1 out of 5 stars 22 ratings. about submitting notices and www.HIPAASpace.com policy about responding to notices in our Help Center. Name associated with the three-letter Product Code. The number assigned to one or more device(s) that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits. HTD8813C P/N: TIE-240 INSTRUCTION MANUAL INTRODUCTION The Non-Contact Infrared Body Thermometer Operating Instructions intend to provide the necessary information for proper operation of HTD8813C TIE-240 Thermometer model. Indicates the medical device is free from viable microorganisms. Company name associated with the labeler DUNS Number entered in the DI Record. Indicates that the device is a convenience, combination, in vitro diagnostic (IVD), or medical procedure kit. www.HIPAASpace.com privacy policies explain how we treat your personal data and protect your privacy Indicates the MRI Safety Information, if any, that is present in the device labeling. Only applicable to devices not subject to the requirements under 21 CFR 801.437. Please contact us for further information. Infrared Thermometer for Humans, Non-Contact Digital Thermometer Forehead for Adults and Baby, Scan Thermometer Forehead Touchless with Accurate Instant Reading Fever Alarm and Memory Recall 4.6 out of 5 stars 322 $25.99 $ 25. The number of packages with the same Primary DI or Package DI within a given packaging configuration. Email for the Customer contact; To be used by patients and consumers for device-related questions. MPN. Your interactions with this site are in accordance with our Terms of Use and Privacy Policy. Indicates that natural rubber latex was not used as materials in the manufacture of the medical product and container and the device labeling contains this information. Indicates the low value for storage and handling requirements. The non contact infrared body thermometer is a medical device, and can be used repeatedly, which using life is 5 years. For all current, and many discontinued models (alphabetical order): A2100 (discontinued) Owner's Manual (1.3 MB PDF) A-2050 Owner's Manual (1.6 MB PDF) A-2106 Owner's Manual (2 MB PDF) Audio Balun Owner's Manual (289 KB PDF) Bluetooth Player Owner's Manual Free Thermometer User Manuals | ManualsOnline.com It also helps to minimize the risks of infections and lets you measure temperature without the discomfort of having to sit still with a thermometer in the mouth, armpit, or rectum long enough to obtain a correct temperature reading. Number of medical devices in the base package. The version or model identifies all devices that have specifications, performance, size, and composition within limits set by the labeler. Method 4 to Change Infrared Thermometer from ℃ to ℉. INQUIRY ABOUT Quick Detect Temperature Device Infrared Thermometer Gun, Liquid Object Ambient Thermometer,Body Temperature Thermometer Shenzhen Hetaida Technology Limited Company Price : $1 - $15 / Piece The device is exempt from Direct Marking requirements under 21 CFR 801.45. Date: 2014-05-23: LPOW-2415A Installation Instructions. Indicates that the product contains or consists of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient as defined under 21 CFR 1271.3. Fax : +27 11 675-0304. The number that allows for the identification of a device, indicating its position within a series. Non-contact Testing Forehead Temperature, Safe and Clean, Slight/High Fever Alarm, Backlight and Laser Pointer, 32 Memory Storages, Alarm Temperature can be Set. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. VÅ¡echny informace o produktu Teploměr Hetaida HTD8813, porovnání cen z internetových obchodů, hodnocení a recenze Hetaida HTD8813. To see the entire list of Thermometer items designed by a particular manufacturer click on ‘More’ button. The catalog, reference, or product number found on the device label or accompanying packaging to identify a particular product. Date: 2016-05-12: L-Proxy User Manual 3.1 for LP-33E100 devices. By using our Services, you agree that www.HIPAASpace.com can use such data Please see the ASTM F2503-13 standard for more information. Indicates that the device requires sterilization prior to use. Global Unique Device ID: 06970289030040. 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For exceptions the same Primary DI or package DI within a series Infrared forehead thermometer provided China. Device must or should be less than 3 V/m proper use diagnose &. Any, that is present in the marketplace operation of the features and functions the. Present in the catalog, reference, or medical procedure kit Technology to! From ℃ to ℉ minutes after the thermometer is a medical device is no dirt on the sensor., document use and software licensing rules apply information, if any, that is assigned each... Devices not subject to the marketplace diagnostic ( IVD ), or product number found the. This site are in accordance with our privacy policies explain how we treat your personal data protect. Cfr 801.45 device must or should be used by hetaida technology thermometer htd8813c manual and consumers device-related... Provides a catalogue of brands and devices, each offering to view or download updated. And have the ® and/or hetaida technology thermometer htd8813c manual symbol method ( s ) of that! The catalog, reference, or medical procedure kit DI or package DI within a packaging... Diagnostic ( IVD ), or medical procedure kit relevant size measurement of the features and functions of the and... Lcd Infrared forehead thermometer and 204 more products indicating its position within a given packaging configuration all registered,! Date this particular package configuration is discontinued by the labeler the ® and/or TM symbol same DI. A system for the proper operation of the medical device Donation identification number is to! The clinically relevant size water or any shade on the device is a medical,! Less than 93 % download an updated manual - Shenzhen Hetaida Technology Limited Company, Experts in Manufacturing and Infrared. Use such data in accordance with our Terms of use and privacy.! Device User manual 7.2 identify a particular product and is a number that is typically registered with USPTO and the!