See 21 CFR 807.3(b) for exceptions. This section is dedicated to Thermometer manuals & user guides which are included in the main list of categories. www.HIPAASpace.com privacy policies explain how we treat your personal data and protect your privacy Non-contact Testing Forehead Temperature, Safe and Clean, Slight/High Fever Alarm, Backlight and Laser Pointer, 32 Memory Storages, Alarm Temperature can be Set. 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. Not all medical products that are NOT made with natural rubber latex will be marked. Fax : +27 11 675-0304. 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 Quality Infrared body thermometer for sale, Infrared body thermometer & Infrared forehead thermometer provided by China Suppliers - Shenzhen Hetaida Technology Limited Company. Servicing and technical facilities are available with on-site or workshop repairs. Please make sure that there is no dirt on the temperature sensor and there is no water or any shade on the forehead. VÅ¡echny informace o produktu Teploměr Hetaida HTD8813, porovnání cen z internetových obchodů, hodnocení a recenze Hetaida HTD8813. He-Taida Infrared Thermometer is a device which is used to measure temperature without actually touching the forehead. 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. Pictures of the above equipment is available on request. Indicates the high value for storage and handling requirements. 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. Indicates that the device is intended for one use or on a single patient during a single procedure. The date by which the label of a device states the device must or should be used. Date: 2020-06-15: LPA/LPA-IP User Manual 3.7. 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 Additional relevant information about the device that is not already captured as a distinct GUDID data attribute. Currently unavailable. Sold as the Mobi Non-Contact Forehead Thermometer, among other names, original equipment manufacturer Hetaida’s htd8813c is a serviceable contactless forehead thermometer. according to the process set out in the U.S. Digital Millennium Copyright Act. Global Unique Device ID: 06970289030040. A general knowledge of infrared thermometers and an understanding of the features and functions of the thermometer are prerequisites for proper use. The non contact infrared body thermometer is a medical device, and can be used repeatedly, which using life is 5 years. Phone : +27 11 475-8504 We don't know when or if this item will be back in stock. Device Name: Non Contact Infrared Body Thermometer. 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. Please contact us for further information. Definition of the common device type associated with the GMDN Preferred Term Code/FDA PT Code. Customers who viewed this item also viewed. The brand name is the name that is typically registered with USPTO and have the ® and/or TM symbol. This user manual is intended to provide the necessary information for the proper operation of the model MS-131002 non-contact infrared body thermometer. Your interactions with this site are in accordance with our Terms of Use and Privacy Policy. 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. HIPAA liability, trademark, document use and software licensing rules apply. General knowledge of Infrared Thermometer and an understanding of the features 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. 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! Measure the body’s temperature hassle-free without touching the forehead with a non-contact infrared thermometer. The device may or may not still be available for purchase in the marketplace. Indicates the MRI Safety Information, if any, that is present in the device labeling. The version or model identifies all devices that have specifications, performance, size, and composition within limits set by the labeler. 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 Name associated with the three-letter Product Code. The date on which a device is manufactured. The version or model found on the device label or accompanying packaging used to identify a category or design of a device. MPN. 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. 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. Version (Model) Number: HTD8813C. Indicates the date this particular package configuration is discontinued by the labeler. functions of the HTD8813 thermometer model are prerequisites for proper use. Please see the ASTM F2503-13 standard for more information. 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. 4.1 out of 5 stars 22 ratings. Please read the manual �irst before using it, if not fully understand the usages, please Method 4 to Change Infrared Thermometer from ℃ to ℉. Date: 2016-05-12: L-Proxy User Manual 3.1 for LP-33E100 devices. Indicates that the device does not require a prescription to use and can be purchased over the counter (OTC). 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). We provide information to help copyright holders manage their intellectual property online. Postal Address : 1091 Gewelhuise Street, Allen’s Nek, 1709, Johannesburg, South Africa, Mail : roy@rseprojects.co.za See ISO/TS 11139. Hetaida Non Contact Infared Body Thermometer HTD8813c Brand: HeTaiDa. Thermometer is an essential device used in every household. Indicates the method(s) of sterilization that can be used for this device prior to device use on the patient. The page provides a catalogue of brands and devices, each offering to view or download an updated manual. 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. - 1 Non-contact Infrared Thermometer - 1 instruction manual -(The packing does not contain batteries). Indicates storage and handling requirements that are required for the device including temperature, humidity, and atmospheric pressure. This non contact thermometer works in ambient temperatures between 5°C & 40°C & where the relative humidity is less than 93%. By using our Services, you agree that www.HIPAASpace.com can use such data General knowledge of Infrared thermometer and an understanding of the features and functions of the HTD8813 thermometer model are prerequisites for proper use. Company name associated with the labeler DUNS Number entered in the DI Record. Classification for devices issued by the FDA. The non contact infrared body thermometer is a medical device, and can be used repeatedly, which using life is 5 years. The unit of measure associated with each clinically relevant size. Product link (buy here): http://gbe.st/301jVnM*Earth Day SPECIAL PROMOTION!!! Email for the Customer contact; To be used by patients and consumers for device-related questions. Page 1 of 1 Start over Page 1 of 1 . 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. Indicates that the device is a convenience, combination, in vitro diagnostic (IVD), or medical procedure kit. Measure the body’s temperature hassle-free without touching the forehead with a non-contact infrared thermometer. Phone number for the Customer contact; to be used by patients and consumers for device-related questions. 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. To see the entire list of Thermometer items designed by a particular manufacturer click on ‘More’ button. HTD8813C. LOYTEC Device User Manual 7.2. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Non Contact Infrared Body Thermometer. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Phone Extension for the Customer contact. HTD Owner's Manuals ; Owner's Manuals. Dimension type for the clinically relevant measurement of the medical device. Indicates the medical device is free from viable microorganisms. 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. Indicates the date the DI Record is published and available via Public Search. Date: 2016-11-14: LPOW-2415B Installation Instructions. MOBI puts excellent innovation, design and technology together to bring smart choices to the marketplace. Copyright © 2007-2021. 99 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. 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. Shenzhen Hetaida Technology Limited Company, Experts in Manufacturing and Exporting Infrared body thermometer,Infrared forehead thermometer and 209 more Products. The number that allows for the identification of a device, indicating its position within a series. Indicates the low value for storage and handling requirements. 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. Numeric value for the clinically relevant size measurement of the medical device. 01- Forehead Thermometer Operation Guidelines. in accordance with our privacy policies. 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. The non contact infrared body thermometer is a medical device, and can be used repeatedly, which using life is 5 years. A … Shenzhen Hetaida Technology Limited Company, Experts in Manufacturing and Exporting Infrared body thermometer,Infrared forehead thermometer and 204 more Products. General knowledge of Infrared thermometer and an understanding of the features and functions of the HTD8813 thermometer model are prerequisites for proper use. 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. Name of the common device type associated with the GMDN Preferred Term Code/FDA PT Code. Indicates that the device requires sterilization prior to use. 6970289038220. Personal care manuals and free healthcare pdf instructions. 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. Indicates whether the device is in commercial distribution as defined under 21 CFR 807.3(b). NOTE Please wait for more than 30 minutes after the thermometer is moved into the measurement environment. Date: 2014-05-23: LPOW-2415A Installation Instructions. Find the personal care product manual that you need at ManualsOnline. This shopping feature will continue to load items when the Enter key is pressed. All rights reserved. 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 … Date: 2016-11-14: LPOW-2460B Installation notes. ... HTD8813C Digital LCD Infrared Forehead Thermometer Non-touch Temperature Measure ... HeTaiDa. If you think somebody is violating your copyrights and want to notify us, you can find information 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. Only applicable to devices not subject to the requirements under 21 CFR 801.437. The forehead thermometer works when ambient temperature is between 5°C & 40°C & the relative humidity is less than 93%. Indicates that the device requires a prescription to use. It uses a multi colour display to diagnose fever & is an accurate forehead thermometer. FDA Premarket submission is not required for this device. 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". All registered trademarks, used in the content, are the property of their owners. Ean. Indicates that the device or packaging contains natural rubber that contacts humans as described under 21 CFR 801.437. 2nd This technology minimizes the risks of infections and ensures you get an accurate temperature reading every … Additional undefined device size not represented in the GUDID Size Type LOV. Thermometer No Contact, Digital Infrared Thermometer Forehead for Adults and Kids, Medical Fever FDA Thermometer Gun w/Alarm, Upgrade Hetaida Thermometer HTD8813C, w/ … Indicates the date the device is no longer held or offered for sale by the labeler on record. It can be used repeatedly and has an estimated life span of three (3) years. 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. GTIN. 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. Number of medical devices in the base package. The catalog, reference, or product number found on the device label or accompanying packaging to identify a particular product. Indicates any special storage requirements for the device. about submitting notices and www.HIPAASpace.com policy about responding to notices in our Help Center. Indicates whether the package is in commercial distribution as defined under 21 CFR 807.3(b). Free Thermometer User Manuals | ManualsOnline.com Organization accredited by FDA to operate a system for the issuance of UDIs. Thermometer, blood pressure monitor, blood glucose meter products from Shenzhen Hetaida Technology Co.,Ltd HETAIDA TECHNOLOGY CO.,LTD. when you use our Services. The Proprietary/Trade/Brand name of the medical device as used in device labeling or in the catalog. The number of packages with the same Primary DI or Package DI within a given packaging configuration. Description. At least one of the products in the combination product must be a device in this case. A …