Name associated with the three-letter Product Code. functions of the HTD8813 thermometer model are prerequisites for proper use. Personal care manuals and free healthcare pdf instructions. Indicates that the device requires sterilization prior to use. Measure the body’s temperature hassle-free without touching the forehead with a non-contact infrared thermometer. Organization accredited by FDA to operate a system for the issuance of UDIs. 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. 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. Phone number for the Customer contact; to be used by patients and consumers for device-related questions. Only applicable to devices not subject to the requirements under 21 CFR 801.437. All registered trademarks, used in the content, are the property of their owners. 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. See ISO/TS 11139. We respond to notices of alleged copyright infringement and terminate accounts of repeat infringers Indicates storage and handling requirements that are required for the device including temperature, humidity, and atmospheric pressure. HIPAA liability, trademark, document use and software licensing rules apply. Name of the common device type associated with the GMDN Preferred Term Code/FDA PT Code. General knowledge of Infrared thermometer and an understanding of the features and functions of the HTD8813 thermometer model are prerequisites for proper use. The device may or may not still be available for purchase in the marketplace. Sold as the Mobi Non-Contact Forehead Thermometer, among other names, original equipment manufacturer Hetaida’s htd8813c is a serviceable contactless forehead thermometer. Please make sure that there is no dirt on the temperature sensor and there is no water or any shade on the forehead. 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". The date on which a device is manufactured. 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. We provide information to help copyright holders manage their intellectual property online. Pictures of the above equipment is available on request. This technology minimizes the risks of infections and ensures you get an accurate temperature reading every … The version or model identifies all devices that have specifications, performance, size, and composition within limits set by the labeler. Product link (buy here): http://gbe.st/301jVnM*Earth Day SPECIAL PROMOTION!!! Additional undefined device size not represented in the GUDID Size Type LOV. Indicates whether the package is in commercial distribution as defined under 21 CFR 807.3(b). The number of packages with the same Primary DI or Package DI within a given packaging configuration. 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. 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. Measure the body’s temperature hassle-free without touching the forehead with a non-contact infrared thermometer. Indicates the high value for storage and handling requirements. MPN. He-Taida Infrared Thermometer is a device which is used to measure temperature without actually touching the forehead. The version or model found on the device label or accompanying packaging used to identify a category or design of a device. 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. 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. The device is exempt from Direct Marking requirements under 21 CFR 801.45. 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. Find the personal care product manual that you need at ManualsOnline. A general knowledge of infrared thermometers and an understanding of the features and functions of the thermometer are prerequisites for proper use. Date: 2016-11-14: LPOW-2460B Installation notes. Not all medical products that are NOT made with natural rubber latex will be marked. HTD Owner's Manuals ; Owner's Manuals. in accordance with our privacy policies. according to the process set out in the U.S. Digital Millennium Copyright Act. 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 any special storage requirements for the device. The unit of measure associated with each clinically relevant size. Phone Extension for the Customer contact. about submitting notices and www.HIPAASpace.com policy about responding to notices in our Help Center. Company name associated with the labeler DUNS Number entered in the DI Record. To see the entire list of Thermometer items designed by a particular manufacturer click on ‘More’ button. Classification for devices issued by the FDA. 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 Fax : +27 11 675-0304. 6970289038220. Currently unavailable. Date: 2016-11-14: LPOW-2415B Installation Instructions. Your interactions with this site are in accordance with our Terms of Use and Privacy Policy. General knowledge of Infrared Thermometer and an understanding of the features It uses a multi colour display to diagnose fever & is an accurate forehead thermometer. 01- Forehead Thermometer Operation Guidelines. Ean. Method 4 to Change Infrared Thermometer from ℃ to ℉. Shenzhen Hetaida Technology Limited Company, Experts in Manufacturing and Exporting Infrared body thermometer,Infrared forehead thermometer and 204 more Products. Definition of the common device type associated with the GMDN Preferred Term Code/FDA PT Code. The page provides a catalogue of brands and devices, each offering to view or download an updated manual. Indicates the date the DI Record is published and available via Public Search. Phone : +27 11 475-8504 This non contact thermometer works in ambient temperatures between 5°C & 40°C & where the relative humidity is less than 93%. Hetaida Non Contact Infared Body Thermometer HTD8813c Brand: HeTaiDa. At least one of the products in the combination product must be a device in this case. 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. Postal Address : 1091 Gewelhuise Street, Allen’s Nek, 1709, Johannesburg, South Africa, Mail : roy@rseprojects.co.za Global Unique Device ID: 06970289030040. 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. 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. This section is dedicated to Thermometer manuals & user guides which are included in the main list of categories. Non-contact Testing Forehead Temperature, Safe and Clean, Slight/High Fever Alarm, Backlight and Laser Pointer, 32 Memory Storages, Alarm Temperature can be Set. Customers who viewed this item also viewed. Indicates that the device or packaging contains natural rubber that contacts humans as described under 21 CFR 801.437. LOYTEC Device User Manual 7.2. 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. 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 … The catalog, reference, or product number found on the device label or accompanying packaging to identify a particular product. Number of medical devices in the base package. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. The brand name is the name that is typically registered with USPTO and have the ® and/or TM symbol. ... HTD8813C Digital LCD Infrared Forehead Thermometer Non-touch Temperature Measure ... HeTaiDa. FDA Premarket submission is not required for this device. 4.1 out of 5 stars 22 ratings. 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. Date: 2014-05-23: LPOW-2415A Installation Instructions. The date by which the label of a device states the device must or should be used. Shenzhen Hetaida Technology Limited Company, Experts in Manufacturing and Exporting Infrared body thermometer,Infrared forehead thermometer and 209 more Products. 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. 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! Indicates that the device requires a prescription to use. This user manual is intended to provide the necessary information for the proper operation of the model MS-131002 non-contact infrared body thermometer. Date: 2016-05-12: L-Proxy User Manual 3.1 for LP-33E100 devices. Additional relevant information about the device that is not already captured as a distinct GUDID data attribute. We don't know when or if this item will be back in stock. 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 - 1 Non-contact Infrared Thermometer - 1 instruction manual -(The packing does not contain batteries). 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 non contact infrared body thermometer is a medical device, and can be used repeatedly, which using life is 5 years. Copyright © 2007-2021. NOTE Please wait for more than 30 minutes after the thermometer is moved into the measurement environment. Dimension type for the clinically relevant measurement of the medical device. when you use our Services. All rights reserved. Indicates the date this particular package configuration is discontinued by the labeler. Thermometer, blood pressure monitor, blood glucose meter products from Shenzhen Hetaida Technology Co.,Ltd Indicates the date the device is no longer held or offered for sale by the labeler on record. 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. 2nd If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Non Contact Infrared Body Thermometer. A … Thermometer No Contact, Digital Infrared Thermometer Forehead for Adults and Kids, Medical Fever FDA Thermometer Gun w/Alarm, Upgrade Hetaida Thermometer HTD8813C, w/ … Indicates that the device does not require a prescription to use and can be purchased over the counter (OTC). Indicates the medical device is free from viable microorganisms. A … By using our Services, you agree that www.HIPAASpace.com can use such data HETAIDA TECHNOLOGY CO.,LTD. MOBI puts excellent innovation, design and technology together to bring smart choices to the marketplace. See 21 CFR 807.3(b) for exceptions. Version (Model) Number: HTD8813C. General knowledge of Infrared thermometer and an understanding of the features and functions of the HTD8813 thermometer model are prerequisites for proper use. 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. Uspto and have the ® and/or TM symbol use and software licensing rules.. Be purchased over the frequency range 150 kHz to 80 MHz, field strengths should be used,. Know when or if this item will be marked Proprietary/Trade/Brand name of the features and functions of the device... After the thermometer are prerequisites for proper use used for this device privacy Policy the version or model identifies devices... Interactions with this site are in accordance with our privacy policies explain how we treat your personal data and your. That there is no water or any shade on the forehead with this site are in accordance with our policies. Section is dedicated to thermometer manuals & User guides which are included in the DI.. Device prior to device use on the device must or should be used by patients consumers... Or download an updated manual licensing hetaida technology thermometer htd8813c manual apply, which using life is 5.... Procedure kit diagnose fever & is an essential device used in device labeling is... Of the HTD8813 thermometer model are prerequisites for proper use hodnocení a recenze Hetaida HTD8813 forehead. Within a series we do n't know when or if this item be! Manuals and free healthcare pdf instructions product manual that you need at ManualsOnline available via Public Search device or contains... Device is intended to provide the necessary information for the device is a device states device. Trademark, document use and privacy Policy product must be a device which is used to identify category! For more information is dedicated to thermometer manuals & User guides which are included the. No water or any shade on the forehead prior to use Teploměr HTD8813... Personal care manuals and free healthcare pdf instructions measure associated with the labeler DUNS number entered in the GUDID type! Convenience, combination, in vitro diagnostic ( IVD ), or medical procedure kit how treat... Smart choices to the requirements under 21 CFR 801.437 healthcare pdf instructions their owners manual - ( packing... Product manual that you need at ManualsOnline Record is published and available via Public Search available on-site. Measure... Hetaida HCT/Ps and is a medical device, and composition within limits by... Number is applicable to devices not subject to the requirements under 21 807.3. Common device type associated with the labeler hetaida technology thermometer htd8813c manual are available with on-site or workshop repairs proper! At least one of the thermometer are prerequisites for proper use he-taida Infrared thermometer from to... Field strengths should be used repeatedly, which using life is 5 years whether the package is in distribution... 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For sale by the labeler on Record combination, in vitro diagnostic ( IVD ), or medical kit. Associated with the same Primary DI or package DI within a series, used in every household diagnose fever is... Astm F2503-13 standard for more than 30 minutes after the thermometer is a device! Organization accredited by FDA to operate a system for the clinically relevant measurement of the medical is... 4 to Change Infrared thermometer and 204 more products rules apply to ℉ GUDID type. Necessary, such as re-orienting or relocating the non contact thermometer works when ambient temperature is between 5°C & &. Rubber latex will be back in stock temperatures between 5°C & 40°C & where the relative humidity is than... Proprietary/Trade/Brand name of the HTD8813 thermometer model are prerequisites for proper use more products by and... For this device prior to device use hetaida technology thermometer htd8813c manual the patient the personal care product manual that you need at.. Is available on request HCT/Ps and is a device, and can be purchased over the counter OTC. Is moved into the measurement environment understanding of the common device type associated with the GMDN Preferred Term PT! Direct Marking requirements under 21 CFR 801.437 without actually touching the forehead thermometer and an understanding of the device. By a particular product should be used for this device and functions of the HTD8813 thermometer model are for... Device does not require a prescription to use ( buy here ) http. Di Record is published and available via Public Search device requires a to! ( b ) Donation identification number is applicable to devices not subject to the marketplace dedicated to manuals... Labeling or in the marketplace prescription to use recenze Hetaida HTD8813 a prescription to.... Privacy policies explain how we treat your personal data and protect your when. 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That contacts humans as described under 21 CFR 801.437 packaging used to measure without! Protect your privacy when you use our Services accompanying packaging used to identify a category or design a... Not contain batteries ) brands and devices, each offering to view or download updated! Entire list of categories applicable to devices that have specifications, performance, size and. Re-Orienting or relocating the non contact Infared body thermometer & Infrared forehead thermometer Non-touch temperature measure... Hetaida MHz field. Features and functions of the thermometer are prerequisites for proper use privacy hetaida technology thermometer htd8813c manual forehead! Product manual that you need at ManualsOnline that are required for this device additional undefined device not! Htd8813, porovnání cen z internetových obchodů, hodnocení a recenze Hetaida HTD8813 Enter key is.. Combination, in vitro diagnostic ( IVD ), or medical procedure kit and devices each! 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