We respond to notices of alleged copyright infringement and terminate accounts of repeat infringers Company name associated with the labeler DUNS Number entered in the DI Record. We are able to provide you with direct, personal support that is designed to assist you In maximising the benefit for any product purchased from ourselves. Details of system including make, model and serial number Details of support required To provide our clients with a premium service, where possible we conduct training and … By using our Services, you agree that www.HIPAASpace.com can use such data Global Unique Device ID: 10846835000184. Additional undefined device size not represented in the GUDID Size Type LOV. The Proprietary/Trade/Brand name of the medical device as used in device labeling or in the catalog. © Biosense Webster, Inc. 2015-2017. Quiz: Could You Have AFib and Not Know It? The CARTO VISITAG™ Module provides access to data collected during the application of RF energy. Indicates the date the DI Record is published and available via Public Search. Indicates any special storage requirements for the device. Indicates the low value for storage and handling requirements. Purchasing expensive, technically advanced biomechanics and medical equipment is not something that our customers do every day. This site is published by Biosense Webster, Inc. which is solely responsible for its content. Here's a look at the facility in action. See 21 CFR 807.3(b) for exceptions. Capitalized product names are trademarks of Biosense Webster, Inc. FDA Premarket submission is not required for this device. The device may or may not still be available for purchase in the marketplace. At least one of the products in the combination product must be a device in this case. Biosense Webster is part of the Johnson & Johnson Family of Companies. Indicates that the device requires sterilization prior to use. Address: ... Official Corespondent Phone Number: 909-839-8998 FDA-Supplied US Agent Information: US Agent Contact Name / Title: DR. MARCIA YAROSS,PH.D. The date by which the label of a device states the device must or should be used. Name of the common device type associated with the GMDN Preferred Term Code/FDA PT Code. Biosense Webster - Found 1k - 5k Employees, 13 Phone Numbers and 11 Emails Many customers enjoy the benefits of knowing that their equipment is maintained and all repair costs covered, under the terms of one of our specifically designed Product Support Contracts. In the US, 4mm Catheters (NAVISTAR®, CELSIUS®, EZ STEER® (NAV and Non-Nav)) have a “General Indication” for creation of endocardial lesions in patients 4 years of age and older. The version or model identifies all devices that have specifications, performance, size, and composition within limits set by the labeler. The device is exempt from Direct Marking requirements under 21 CFR 801.45. AccessGUDID - Biosense Webster (08718375860168)- D-1221-21-S / 39F-54R autoclavable conn. cable We use cookies to improve your experience on our website. Numeric value for the clinically relevant size measurement of the medical device. 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. Copyright © 2007-2020. Bertaglia E, Bella PD, Tondo C, Proclemer A, Bottoni N, De Ponti R, et al. As part of the Biosense Webster policy of continuous product development we reserve the right to change product specifications without prior notification. Details of system including make, model and serial number. The catalog, reference, or product number found on the device label or accompanying packaging to identify a particular product. By using this site, you agree to our Legal Notice and Privacy Policy. In honor of American Heart Month, we sat down with a ticker expert to learn about things most people may not know about their hearts—and advances that could change cardiac care. Indicates storage and handling requirements that are required for the device including temperature, humidity, and atmospheric pressure. This support includes: Our technical support staff are fully trained by the original equipment manufacturers, and maintain their product knowledge by participating in a continual training programme. Important Information: Prior to use, refer to the “instructions for use” supplied with these devices for indications, contraindications, side effects, suggested procedure, warnings and precautions. Your use of the information on this site is subject to the terms of our Legal Notice. S.p.A., BIOSENSE WEBSTER Via del Mare 56 00040 Pomezia, Roma, Italy Tel: +39 06 911 1735 This site is published by Biosense Webster, Inc. which is solely responsible for its contents. Always verify catheter tip location using fluoroscopy or IC signals and consult the CARTO® System User Guide regarding recommendations for fluoroscopy use. Fax Number +972-4-8131112. The number that allows for the identification of a device, indicating its position within a series. 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. In the US, Biosense Webster THERMOCOOL® non-navigational Catheters are indicated for the treatment of Type I Atrial Flutter in patients 18 years of age or older. CARTO VISITAG™ Module settings are user defined based on the user’s clinical experience and medical judgment. www.HIPAASpace.com privacy policies explain how we treat your personal data and protect your privacy 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). Find 5 listings related to Biosense Webster in Irwindale on YP.com. Please see the ASTM F2503-13 standard for more information. Indicates whether the package is in commercial distribution as defined under 21 CFR 807.3(b). Biosense Webster, Johnson & Johnson. Touring the Johnson & Johnson Institute: A Behind-the-Scenes Look at Where Doctors and Nurses Learn Cutting-Edge Care, This site uses cookies as described in our. Dimension type for the clinically relevant measurement of the medical device. For World Heart Day, take this quiz to test your AFib know-how. Indicates that the device is a convenience, combination, in vitro diagnostic (IVD), or medical procedure kit. If you require technical support please open a ticket using the contact form below or for urgent matters call us on 01245 495002. We provide information to help copyright holders manage their intellectual property online. Not only is it extremely important to choose the best product for your immediate needs, but you should also carefully consider the long-term support that you may require to ensure you continue to get the very best from your new system. The site you’re being redirected to is a branded pharmaceutical website. See ISO/TS 11139. See reviews, photos, directions, phone numbers and more for Biosense Webster locations in Irwindale, CA. Biosense Webster. In the U.S., THERMOCOOL® Navigation Catheters are approved for drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with CARTO® Systems (excluding NAVISTAR® RMT THERMOCOOL® Catheter). Biosense Webster’s phone number is (909) 839-8500 What is Biosense Webster’s official website? 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. Third party trademarks used herein are trademarks of their respective owners. Classification for devices issued by the FDA. Some 33 million people worldwide have atrial fibrillation, a form of heart disease that can lead to stroke. It's one hard-working organ, pumping 1.5 gallons of blood every minute and beating around 100,000 times a day. The Registered Agent on file for this company is C T Corporation System and is located … Phone Number +972-4-8131111. Indicates the MRI Safety Information, if any, that is present in the device labeling. Tel: +353 1466520. 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. Phone number for the Customer contact; to be used by patients and consumers for device-related questions. However technical support is not only about understanding the technical aspects of your equipment, we also understand and are able to assist in the specialist applications that our products are used in. Applicant: Biosense Webster, Inc. 33 Technology Drive Irvine, CA 92618, USA Tel. As part of the Biosense Webster policy of continuous product development we reserve the right to change product specifications without prior notification. For World Heart Day, take this quiz to test your AFib know-how. Biosense Webster, Inc. is a Texas Foreign For-Profit Corporation filed on August 31, 2012. The brand name is the name that is typically registered with USPTO and have the ® and/or TM symbol. Phone Extension for the Customer contact.

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