Product Attributes

The attributes that are available for a product depend on the associated product family type.

Key for Product Family Type:

— FV - flu vaccine

— P - pharmaceutical

Create a Product

— MD - medical device

— PMD - pharmaceutical-medical device

— V - veterinary

— All - all product family types


Attribute	Product Family Type	Description
Alternate Product Description	MD, PMD	The product description for printing Certificates for Foreign Government (CFG).
Applicable Standards	MD, PMD	Standards (codes) to which the device adheres.
CE Date	MD, PMD	Date when the CE mark was granted.
CE Marked	MD, PMD	Conformité Européenne passport of free trade; signifies the device has been declared by an authorized company to conform to a uniform and high degree of safety as measured by technical standards and controlled by your quality management system.
Combined Pharmaceutical Dose Form	FV, P, PMD	The combined pharmaceutical dose form is a single term to describe two or more manufactured dose forms that are intended to be combined to create a single administrable dose form. — The field is displayed on the View/Modify Product Attributes page when more than one component is associated to the Product. — The values in the field are displayed if there are active Dosage/Pharmaceutical Form Data Administration values with RMS values assigned mapped to values from SPOR Master Lists > Combined Pharmaceutical Dose Form
Component Owner/ RA Responsible	All	RA person responsible for the component.
Conformity Assessment Path	MD, PMD	Path taken for conformity assessment.


Declaration of Conformity Completed	MD, PMD	Indicates whether there exists a signed statement of compliance to a recognized national or international standard provided in a product submission in lieu of providing data demonstrating conformance to the recognized standard.
Drug Safety Code	FV, P, V, PMD	Safety code for a drug.
EC Cert	MD, PMD	Design certs for class III products.
Equipment Type	MD, PMD	The type of equipment as stated in the Declarations of Conformity.
Attribute	Product Family Type	Description
EU Class	MD, PMD	Indicates the class of increasing risk to a patient as described by the MDD; classes are described as follows: — Class I - devices that pose a low risk to the patient and, except for sterile products or measuring devices, can be self-certified by the manufacturer — Class IIa - devices that pose a medium risk; may require assessed quality systems to the ISO 9000/EN46000 standards; invasive in their interaction with the human body, methods of invasion are limited to natural body orifices; may also include therapeutic devices used in diagnosis or in wound management — Class IIb - devices that pose a medium risk that may require assessed quality systems to the ISO 9000/ EN46000 standards; third-party certification is required; partially or totally implantable in the human body, and may modify the biological or chemical composition of body fluids — Class III - devices that pose a high risk and require design/ clinical trial reviews, product certification and an assessed quality system; all third-party product and system certification must be conducted by a European notified body (or designee through formal agreement); these devices affect the functioning of vital organs and/or lifesupport systems
EU Classification Rule	MD, PMD	EU Classification Rule: Rule 1 through Rule 18, and Rule 99.
EURD ID	FV, P, PMD	The EURD ID is a unique identification number that is used for the submission process of all the entries and procedures in the EURD list.


Family Code	All	The code for the product family code you are associating the product with.
Family Name	All	The name of the product family you are associated the product with.
Attribute	Product Family Type	Description
FDA Device Class	MD, PMD	FDA classification based on risk: — Class I - least risk-laden for which general controls are sufficient to ensure safety and effectiveness — Class II - devices for which general controls are determined to be insufficient to provide reasonable assurance of safety and effectiveness, but for which exists sufficient information to establish a performance standard to provide assurance — Class III - devices for which there is insufficient information to determine the adequacy of general controls, performance standards or special controls providing reasonable assurance of safety and effectiveness (usually life-supporting or life-sustaining devices)
FDA Product Code	MD, PMD	Product codes with which the device is associated; identify the product in further detail; for example, Manual Surgical Instruments for General Use contains several product codes including GAB (disposable suturing needle), GDX (scalpel), HTD (forceps) and HRQ (hemostat).
FDA Regulation Number	MD, PMD	Generic category that is represented by a separate classification regulation found in Title 21 Code of Federal Regulations parts 862-89.
Global Harmonization Task Force Class (GHTF)	MD, PMD	Class as defined by the GHTF with values 1, 2, 3.
Global Medical Device Nomenclature (GMDN) Code	MD, PMD	Classification system that allows for the classification of all medical devices put onto the market as defined in the three European Directives.


Indications/Intended Use	FV, P, PMD, V	A display-only field on the Product Attributes page showing the indications from the product detail sets associated with the product.
Intended Use	MD, PMD	Intended use of a device (based on Annex 1, I.1; Annex X, 1.1; Annex X, 2.1).
Medical Device Link	MD, PMD	Number assigned to the device through MDL.
Attribute	Product Family Type	Description
Product Add Comment	All	Comments you want to share with others in a discussion thread. Will be displayed in the Product Comments box, stamped with the date and time you enter the information and your user ID.
		*Note:* The Product Add Comment field is available on the Create/Modify Product Attributes pages only.

Product Category	FV, P, PMD	Classification value for product category.
Product Code	All	The company-specific code for the product. On some pages, the product name is shown with the product code to identify a product. For example, Origine 390 could identify a product that has the name Origine and the code 390.
Product Comments	All	The discussion thread that includes all comments entered by users; includes the date and time the comments were entered and the user ID of the person who entered them.
Product Concerned Parties	All	Users who may be copied on notifications about this entity; use semi-colons (;) to separate e-mail addresses.
Product Description	All	Text that describes the product.
Product Dose Form	FV, P, PMD, V	The physical form in which a drug is produced and dispensed. This may be defined at the product level, the component level, or both.
Product Family Type	All	The type of product family with which the product is associated.
Product Keywords	All	Words you can use to search for the product.
Product Manufacturing Location	MD, PMD	Locations of the device manufacturers (assuming there are no product detail sets).
Product Name	All	The standard product name recognized internally and across countries. On some pages, the product name is shown with the product code to


		identify a product. For example, Origine 390 could identify a product that has the name Origine and the code 390.
Product National Drug Code	FV, P, PMD, V	NDC; identifies the labeler, product and trade package size.
Attribute	Product Family Type	Description
Product Route of Administration	FV, P, PMD	How the product is to be administered. The values that appear for this attribute are based on the dosage form you selected. You may select multiple routes of administration. This may be defined at the product level, the component level, or both.
Product Shelf Life	MD, PMD	Standard shelf life of the device.
Product Status	All	The status of the product.
Product Status Date	All	The date the product status is effective.
Product Sterilization	MD, PMD	Defines the type of sterilization the device provides.
Product Strength Measure 1	FV, P, PMD, V	The minimum value used to define the product strength.
Product Strength Measure 2	FV, P, PMD, V	The maximum value used to define the product strength.
Product Strength Unit 1	FV, P, PMD, V	The measurement used to quantify the minimum strength.
Product Strength Unit 2	FV, P, PMD, V	The measurement used to quantify the maximum strength.
Reason	All	Reason for creating, modifying or deleting a product.
Reason for Comments		Comments related to reason entered by users.
Reason for Termination/ Withdrawal	All	The reason that the product was terminated or withdrawn.
Summary of Technical Documentation (STED)	MD, PMD	Your STED IDs that apply to the product.
Tech File Number	MD, PMD	Identifies the technical file that is submitted to the EU for the device.
UMDNS Code	MD, PMD	UMDNS computer code that is used in ECRI databases and publications, as well as in thousands of health care institutions worldwide for the device.
User ID		The user name to validate user identity.
Password		The user password to validate user identity.