Unique Device Identification definition

Unique Device Identification. (‘UDI’) means a series of numeric or alphanumeric characters that is created through internationally accepted device identification and coding standards and that allows unambiguous identification of specific devices on the market;
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Examples of Unique Device Identification in a sentence

  • These provisions include the requirement to provide a UDI on the device label and packages (21 CFR 801.20), format dates on the device label in accordance with 21 CFR 801.18, and submit data to the Global Unique Device Identification Database (GUDID) (21 CFR 830 Subpart E).

  • Reported brand names and device identifiers will be validated against the information from the Global Unique Device Identification Database (GUDID).

  • It consists of: • a requirement that economic operators must be able to identify who supplied them and to whom they have supplied medical devices; • a requirement that manufacturers fit their devices with a Unique Device Identification (UDI) which allows traceability.

  • The FDA Unique Device Identification System final rule (UDI Rule) requires device labelers (typically, the manufacturer) to: – Include a unique device identifier (UDI) on device labels and packages, except where the rule provides for an exception or alternative.

  • All information re- quired by this subpart shall be sub- mitted electronically to FDA’s Global Unique Device Identification Database (GUDID) in a format that we can proc- ess, review, and archive, unless the la- beler has obtained a waiver from elec- tronic submission of unique device identifier (UDI) data.

  • Unique Device Identification (UDI) System for Medical Devices (Final Document);http://www.ghtf.org/documents/ahwg/AHWG-UDI-N2R3.pdf.

  • Zimmer Biomet Unique Device Identification (UDI) RequirementsBoth Zimmer Biomet and suppliers are required to meet FDA and UE MDR 2017/745 requirements for UDI through labeling and/or product marking for products sold in the US, and / or EU (European Union) and EFTA (European Free Trade Association, including Switzerland) markets as defined by: 21CFR parts 16, 801, 803, 806, 810, 814, 820, 821, 822,830, EU MDR 2017/745 and Zimmer BiometCorporate Procedures.

  • These are subject to existing regulations and requirements, such as Unique Device Identification (UDI).

  • BEUC supports the main elements of possible cooperation in the medical devices sector as outlined in the EU position on medical devices in TTIP11, including the recognition of manufacturers quality management system (QMS) audits ( see also point 3), convergence of system for identifying and tracing medical devices (Unique Device Identification – UDI) and of models form marketing submission (Regulated Product submission).

  • Implementing Unique Device Identification in Electronic Health Record Systems: Organizational, Workflow, and Technological Challenges.

Related to Unique Device Identification

  • DoD item unique identification means a system of marking items delivered to DoD with unique item identifiers that have machine- readable data elements to distinguish an item from all other like and unlike items. For items that are serialized within the enterprise identifier, the unique item identifier shall include the data elements of the enterprise identifier and a unique serial number. For items that are serialized within the part, lot, or batch number within the enterprise identifier, the unique item identifier shall include the data elements of the enterprise identifier; the original part, lot, or batch number; and the serial number.

  • Automatic identification device means a device, such as a reader or interrogator, used to retrieve data encoded on machine-readable media.

  • User Identification means any unique user name (i.e., a series of characters) that is assigned to a person or entity by the Insured.

  • Positive identification means a method of identifying a person that does not rely on the use of a private personal identifier such as a password, but must use a secure means of identification that includes any of the following:

  • Baggage Identification Tag means a document issued by the carrier solely for identification of checked baggage, part of which is given to the passenger as a receipt for the passenger’s checked baggage and the remaining part is attached by the carrier onto a particular piece of the passenger’s checked baggage.

  • Unique identifier means a number or other identifier assigned by protocols established by the Nationwide Mortgage Licensing System and Registry.

  • Radio frequency identification (RFID means an automatic identification and data capture technology comprising one or more reader/interrogators and one or more radio frequency transponders in which data transfer is achieved by means of suitably modulated inductive or radiating electromagnetic carriers.

  • Hazard identification means the identification and documenting of existing or expected hazards to the health and safety of persons, which are normally associated with the type of construction work being executed or to be executed;

  • Automatic Location Identification or "ALI" is the automatic display at the Public Safety Answering Point (PSAP) of the caller's telephone number, the address/location of the telephone and supplementary emergency services information for Enhanced 911 (E911).

  • Proper identification as used above, means information generally deemed sufficient to identify you, which includes documents such as a valid driver’s license, social security account number, military identification card, and credit cards. Only if you cannot identify yourself with such information may the ICRA require additional information concerning your employment and personal or family history in order to verify your identity.

  • Registry identification card means a document issued by the department pursuant to [section

  • Caller identification service means a service that allows a telephone subscriber to have the telephone number, and, where available, name of the calling party transmitted contemporaneously with the telephone call, and displayed on a device in or connected to the subscriber’s telephone.

  • Identification card means an identification card issued under Title 53,

  • Unique item identifier means a set of data elements marked on items that is globally unique and unambiguous. The term includes a concatenated unique item identifier or a DoD recognized unique identification equivalent.

  • Unique item identifier type means a designator to indicate which method of uniquely identifying a part has been used. The current list of accepted unique item identifier types is maintained at http://www.acq.osd.mil/dpap/pdi/uid/uii_types.html.

  • Identification Information means, for an individual - the passport/ID information specified while the Client Registration.

  • Automatic Location Identification Gateway or "ALI Gateway" is a computer facility into which CLEC delivers Automatic Location Identification (ALI) data for CLEC Customers. Access to the ALI Gateway will be via a dial-up modem using a common protocol. "Automatic Number Identification" or "ANI" is the Billing telephone number associated with the access line from which a call originates. ANI and Calling Party Number (CPN) usually are the same number. "Automatic Route Selection" or "ARS" is a service feature that provides for automatic selection of the least expensive or most appropriate transmission facility for each call based on criteria programmed into a circuit Switch routing table or system.

  • Identification means the process of determining a person’s identity through a database search against multiple sets of data (one-to-many check);

  • Patient identifying information means an insured's address, telephone number, facsimile number, electronic mail address, photograph or likeness, employer, employment status, social security number, or any other information that is likely to lead to the identification of the insured.

  • Biometric identifier means a retina or iris scan, fingerprint, voiceprint, or scan of hand or face geometry.

  • Automatic Number Identification or "ANI" means a Feature Group D signaling parameter which refers to the number transmitted through a network identifying the billing number of the calling party.

  • Vehicle identification number means the number, letters, or combination of numbers and letters

  • Personal Identification Number (PIN) means a confidential four-digit code number provided to a calling card customer to prevent unauthorized use of his/her calling card number. LIDB and/or the LIDB administrative system can store a PIN for those line numbers that have an associated calling card.

  • Common Language Location Identifier (CLLI) means the codes that provide a unique eleven (11) character representation of a network interconnection point. The first eight (8) characters identify the city, state and building location, while the last three (3) characters identify the network component.

  • EPA identification number means the number assigned by EPA to each generator, transporter, and treatment, storage, or disposal facility.

  • Unique User ID means a string of characters that identifies a specific user and which, in conjunction with a password, passphrase or other mechanism, authenticates a user to an information system.