Category B Device definition

Category B Device means a non-experimental investigational device that is eligible for Medicare coverage.

Examples of Category B Device in a sentence

  • Category B Device Institutional providers must bill the Category B IDE number on a 0624 revenue code line with charges in the covered charges field.

  • Category B Device Effective for dates of service on or before December 31, 2007, practitioners must bill the Category B IDE device on a line with a QA modifier (FDA IDE) along with the IDE number.

  • Category B: Device intended to protect front seat passenger(s) other than the driver in the event of a frontal collision.

  • The approach expands the continuous-time deterministic dynamics of the system with discrete-time stochastic behavior.The analysis of PEM fuel cell operating principles and degradation phenomena served as a starting point for this research.

  • Category B Device: A non-experimental and/or investigational medical or health-related device where the incremental risk is the primary question (e.g., underlying questions of safety and effectiveness of the device type have been resolved), or it is known that the device type can be safe and effective because, for example, other manufacturers have obtained FDA approval for that type of device.

  • Category B Device: This is a classification assigned by the Food and Drug Administration in which the initial questions of safety and effectiveness of that device type have been resolved, for example, FDA premarket approval or clearance has been obtained.

  • Category B Device: This is a classification assigned by the Food and Drug Administration in which the initial questions of safety and effectiveness of that device type have been resolved, for example, FDA premarket approval or clearance has been obtained.Category III codes (or T codes): The American Medical Association (AMA) developed Category III CPT codes to track the utilization of emerging technologies, services and procedures.

Related to Category B Device

  • Category 3 means those affected lands and support facilities if those lands supported operations which were not completed or substantially completed prior to July 1, 1973 (the effective date of the Wyoming Environmental Quality Act) and any affected lands or support facilities taken out of use on or after July 1, 1973 and before May 25, 1975 (the effective date of the Division’s 1975 Rules and Regulations).

  • Category B means that the base prospectus shall include all the general principles related to the information required, and only the details which are unknown at the time of the approval of the base prospectus can be left in blank for later insertion in the final terms;

  • Orthotic device means a custom-fitted or custom-fabricated medical device that is applied to a part of the human body to correct a deformity, improve function, or relieve symptoms of a disease.

  • Prosthetic device means a replacement, corrective, or supportive device, other than contact lenses and dental prosthesis, dispensed pursuant to a prescription, including repair or replacement parts for that device, worn on or in the body to do 1 or more of the following:

  • Product Category means the applicable category which best describes the product as listed in this Section 94508.

  • Category 1 means medical education activities that have been designated as Category 1 by the Accreditation Council for Continuing Medical Education (ACCME), the American Osteopathic Association (AOA), a state medical society, or an equivalent organization.

  • Category A means the relevant information which shall be included in the base prospectus. This information cannot be left in blank for later insertion in the final terms;

  • Clinical categories means the groups into which hospital treatments are categorised by type, e.g., brain and nervous system, kidney and bladder, and digestive system. At the time of writing there were 38 categories in the Medicare clinical categories system.

  • Reference biological product means the single biological product licensed pursuant to 42 U.S.C.

  • Protective device means an individually fabricated mechanical device or physical barrier, the use of which is incorporated in the individualized written plan of service. The use of a protective device is intended to prevent the minor child from causing serious self-injury associated with documented, frequent, and unavoidable hazardous events.

  • Approved Device means a device described in Subsection 20A-21-201(4) used to

  • Anti-Static Product means a product that is labeled to eliminate, prevent, or inhibit the accumulation of static electricity. “Anti-Static Product” does not include “Electronic Cleaner,” “Floor Polish or Wax,” “Floor Coating,” and products that meet the definition of “Aerosol Coating Product” or “Architectural Coating.”

  • single-use device means a device that is intended to be used on an individual patient during a single procedure.

  • Category 4 Data is data that is confidential and requires special handling due to statutes or regulations that require especially strict protection of the data and from which especially serious consequences may arise in the event of any compromise of such data. Data classified as Category 4 includes but is not limited to data protected by: the Health Insurance Portability and Accountability Act (HIPAA), Pub. L. 104-191 as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH), 45 CFR Parts 160 and 164; the Family Educational Rights and Privacy Act (FERPA), 20 U.S.C. §1232g; 34 CFR Part 99; Internal Revenue Service Publication 1075 (xxxxx://xxx.xxx.xxx/pub/irs-pdf/p1075.pdf); Substance Abuse and Mental Health Services Administration regulations on Confidentiality of Alcohol and Drug Abuse Patient Records, 42 CFR Part 2; and/or Criminal Justice Information Services, 28 CFR Part 20.

  • Cephalometric device means a device intended for the radiographic visualization and measurement of the dimensions of the human head.

  • Assistive device means any item, piece of equipment, or product system which is used to increase, maintain, or improve the functional capabilities of an individual with a disability in the workplace or on the job. “Assistive device” does not mean any medical device, surgical device, or organ implanted or transplanted into or attached directly to an individual. “Assistive device” does not include any device for which a certificate of title is issued by the state department of transportation, but does include any item, piece of equipment, or product system otherwise meeting the definition of “assistive device” that is incorporated, attached, or included as a modification in or to such a device issued a certificate of title.

  • MSAA Indicator Technical Specifications document means, as the context requires, either or both of the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Indicator Technical Specifications November 5, 2018 Version 1.3” and the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Target and Corridor-Setting Guidelines” as they may be amended or replaced from time to time;

  • Category 2 Training: This category includes services related to training state employees to understand and apply Agile concepts and tools.

  • Runtime Product means the version specific files and application program interfaces (APIs) specified in the RUNTIME.TXT file provided with SAP Crystal Reports 2008, SAP Crystal Reports for Eclipse 2.0, and SAP Crystal Reports for Visual Studio 2010.

  • Mobile Device means a computing device, typically smaller than a notebook, which runs a mobile operating system, such as iOS, Android, or Windows Phone. Mobile Devices include smart phones, most tablets, and other form factors.

  • Diagnostic Product means In Vitro Diagnostics, In Vivo Diagnostic Agents and any product used for Diagnosis.

  • Step therapy protocol means a protocol or program that establishes the specific

  • Managed Device means any device on which any Affiliate in the Enterprise directly or indirectly controls one or more operating system environments. Examples of Managed Devices can be found in the Product Terms.

  • Massive Multiauthor Collaboration Site (or “MMC Site”) means any World Wide Web server that publishes copyrightable works and also provides prominent facilities for anybody to edit those works. A public wiki that anybody can edit is an example of such a server. A “Massive Multiauthor Collaboration” (or “MMC”) contained in the site means any set of copyrightable works thus published on the MMC site.

  • Edible cannabis product means cannabis product that is intended to be used, in whole or in part, for human consumption, including, but not limited to, chewing gum, but excluding products set forth in Division 15 (commencing with Section 32501) of the Food and Agricultural Code. An edible cannabis product is not considered food, as defined by Section 109935 of the Health and Safety Code, or a drug, as defined by Section 109925 of the Health and Safety Code.

  • Therapeutic diet means meals served that are soft, low-fat, low-sodium or controlled calorie.