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. The number that allows for the identification of a device, indicating its position within a series. A general knowledge of infrared thermometers and an understanding of the features and functions of the thermometer are prerequisites for proper use. The version or model identifies all devices that have specifications, performance, size, and composition within limits set by the labeler. We provide information to help copyright holders manage their intellectual property online. - 1 Non-contact Infrared Thermometer - 1 instruction manual -(The packing does not contain batteries). Please see the ASTM F2503-13 standard for more information. Additional relevant information about the device that is not already captured as a distinct GUDID data attribute. 4.1 out of 5 stars 22 ratings. Copyright © 2007-2021. Date: 2014-05-23: LPOW-2415A Installation Instructions. Phone Extension for the Customer contact. Shenzhen Hetaida Technology Limited Company, Experts in Manufacturing and Exporting Infrared body thermometer,Infrared forehead thermometer and 209 more Products. Phone : +27 11 475-8504 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 page provides a catalogue of brands and devices, each offering to view or download an updated manual. Version (Model) Number: HTD8813C. This section is dedicated to Thermometer manuals & user guides which are included in the main list of categories. Indicates whether the device is in commercial distribution as defined under 21 CFR 807.3(b). Indicates that the device does not require a prescription to use and can be purchased over the counter (OTC). 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. HETAIDA TECHNOLOGY CO.,LTD. according to the process set out in the U.S. Digital Millennium Copyright Act. Pictures of the above equipment is available on request. Only applicable to devices not subject to the requirements under 21 CFR 801.437. Description. If you think somebody is violating your copyrights and want to notify us, you can find information 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. 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. Classification for devices issued by the FDA. Please read the manual �irst before using it, if not fully understand the usages, please Organization accredited by FDA to operate a system for the issuance of UDIs. 2nd All rights reserved. A … Postal Address : 1091 Gewelhuise Street, Allen’s Nek, 1709, Johannesburg, South Africa, Mail : roy@rseprojects.co.za www.HIPAASpace.com privacy policies explain how we treat your personal data and protect your privacy 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 any special storage requirements for the device. Indicates that the device is a convenience, combination, in vitro diagnostic (IVD), or medical procedure kit. Date: 2020-06-15: LPA/LPA-IP User Manual 3.7. Currently unavailable. It uses a multi colour display to diagnose fever & is an accurate forehead thermometer. Indicates the medical device is free from viable microorganisms. A … Indicates that the device requires sterilization prior to use. This shopping feature will continue to load items when the Enter key is pressed. Quality Infrared body thermometer for sale, Infrared body thermometer & Infrared forehead thermometer provided by China Suppliers - Shenzhen Hetaida Technology Limited Company. Free Thermometer User Manuals | ManualsOnline.com Indicates that the device is intended for one use or on a single patient during a single procedure. Non-contact Testing Forehead Temperature, Safe and Clean, Slight/High Fever Alarm, Backlight and Laser Pointer, 32 Memory Storages, Alarm Temperature can be Set. LOYTEC Device User Manual 7.2. Number of medical devices in the base package. Indicates storage and handling requirements that are required for the device including temperature, humidity, and atmospheric pressure. Indicates the date the device is no longer held or offered for sale by the labeler on record. 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. Hetaida Non Contact Infared Body Thermometer HTD8813c Brand: HeTaiDa. The number of packages with the same Primary DI or Package DI within a given packaging configuration. 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. 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. 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. Additional undefined device size not represented in the GUDID Size Type LOV. Find the personal care product manual that you need at ManualsOnline. The Proprietary/Trade/Brand name of the medical device as used in device labeling or in the catalog. To see the entire list of Thermometer items designed by a particular manufacturer click on ‘More’ button. 99 Thermometer, blood pressure monitor, blood glucose meter products from Shenzhen Hetaida Technology Co.,Ltd Indicates that the device or packaging contains natural rubber that contacts humans as described under 21 CFR 801.437. 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 date on which a device is manufactured. Indicates the MRI Safety Information, if any, that is present in the device labeling. Thermometer is an essential device used in every household. Fax : +27 11 675-0304. Page 1 of 1 Start over Page 1 of 1 . The non contact infrared body thermometer is a medical device, and can be used repeatedly, which using life is 5 years. Phone number for the Customer contact; to be used by patients and consumers for device-related questions. 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 VÅ¡echny informace o produktu Teploměr Hetaida HTD8813, porovnání cen z internetových obchodů, hodnocení a recenze Hetaida HTD8813. See ISO/TS 11139. Not all medical products that are NOT made with natural rubber latex will be marked. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Non Contact Infrared Body Thermometer. General knowledge of Infrared thermometer and an understanding of the features and functions of the HTD8813 thermometer model are prerequisites for proper use. GTIN. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Indicates that the device requires a prescription to use. FDA Premarket submission is not required for this device. Measure the body’s temperature hassle-free without touching the forehead with a non-contact infrared thermometer. 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. 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. Date: 2016-05-12: L-Proxy User Manual 3.1 for LP-33E100 devices. He-Taida Infrared Thermometer is a device which is used to measure temperature without actually touching the forehead. functions of the HTD8813 thermometer model are prerequisites for proper use. 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. , or medical procedure kit thermometer - 1 non-contact Infrared thermometer if this item will back... Page provides a catalogue of brands and devices, each offering to view or download updated... If this item will be back in stock data attribute counter ( OTC ) must or should be than! Www.Hipaaspace.Com can use such data in accordance with our privacy policies that there is no water or any on! Device must or should be used repeatedly, which using life is 5 years or packaging contains natural that... Than 93 % - 1 instruction manual - ( the packing does not contain batteries ) Hetaida. 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