Calyx RIM for Registrations

Component Attributes

The attributes that are available for a component depend on the component type.

Key for Component Type:

  • FV for the flu vaccine component type
  • P for the pharmaceutical component type
  • MD for the medical device component type
  • PMD for the pharmaceutical-medical device component type 
  • V for the veterinary component type
  • All for all component types
Attribute Component Type Description
Active Ingredients FV Active ingredients available for selection that are associated with the product family.
Allergenicity Indicator MD Specifies whether the device contains allergens and/or materials of concern.
Component Add Comment All Comments you want to share with others in a discussion thread. Comments are stamped with the date and time you enter the information, and your user ID.
Component Code All The Code for the specific component.
Component Comments All
The discussion thread that includes all comments entered by users, plus the date and time the comments were entered and the user ID of the person who entered them.
Note: Comments are available on the Modify Components page.
Component Concerned Parties All Users who may be copied on notifications about this entity. Use semi-colons (;) to separate e-mail addresses.
Component Description All Text that describes the component.
Component Form FV, P, PMD, V The physical form in which this component is produced and dispensed. For example: tablet, capsule, powder, or liquid.
Component Keywords All Words you can use to search for the component.
Component Manufacturing Location MD, PMD Locations of the device manufacturers (assuming there are no product detail sets).
Component Name All Name given to identify the specific component. If this is a single component product, the name would most likely be the same as the product name.
Component National Drug Code FV, PMD, V

Universal product identifier for human drugs. There are three segments to the Component National Drug Code:

  • Labeler code - pertains to the manufacturer
  • Product code - pertains to the bulk product
  • Packaging code - pertains to the presentation (e.g: 5-pack, 10-pack, bottle, blister, etc.)

For devices, NDC only applies to medical devices that have a drug component(s).

Component Owner/ RA Responsible FV, MD, PMD, V RA person responsible for the component.
Component Route of Administration FV, P, PMD How the component 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 field may be left blank because the component itself may not administered, rather it is the combination of components that define the administration.
Component Sterilization MD, PMD Defines the type of sterilization the device provides.
Component Type All Defines the type of component. The component type is based on the entity type to which it is associated: pharmaceutical entity type, medical devices entity type, or a pharmaceutical-medical devices combination.
Device Alternate Material MD The alternative material(s) of the device.
Device Material MD The material(s) of the device.
Device Nomenclature MD The term for the device from the specified nomenclature system.
Device Type MD The type of device.
Device Usage MD The number of times that the device may be used.
Family Code All The code of the product family to which this component is associated.
Family Name All The name of the product family to which this component is associated.
Model Number MD Specifies the device model or reference number, where applicable, in text.
Product Name All The standard product name recognized internally and across countries.
Product Family Type All The product family type to which this component is associated.
Product Name All The name of the product to which the component is associated.
Sterility Indicator MD Specifies whether the device is supplied as sterile.
Sterilization Requirement Indicator MD Specifies whether the device shall be sterilized before use.