Medical Device example - multiple components

This is an example of a medical kit used in standard hospital steam sterilisation. It consists of one reusable tube (component 1) and multiple indicator capsules (component 2)   Note: Data provided as an example on how the Healthcare attributes can be populated for a similar product and not meant to represent any product or manufacturer. This is an example and not advice on actual product regulatory information. Pricing data has not been included on examples.

 

Trade Item Description			GS1 Load Challenge Test Kit - 250 x High Precision Sterilant Specific Indicators
Trade Item Channel Code			HEALTHCARE			If the UNSPSC Segment level code = 51000000 (Drugs and Pharmaceutical Products), 41000000 or 42000000 (Medical Devices) THEN item Trade Channel Code must be "HEALTHCARE".
Additional Trade Item Classification Code / Description			42281530			UNSPSC code list can be found in the NPC Cook book under Product Classifications. Please use version 19.
GPC Category Code			10005844			GPC code list can be found in the NPC Cook book under Product Classifications.

Medicines or Devices may have multiple components. The attributes shown below identify those unique (C)omponents and further, identify (D)etails within a component.
 

Healthcare Component Type C1			D (Device)			Where Healthcare Component Type is M - Medicine or D – Device, there must be at least 1 component detail (C1D1) for the base unit.
						These attributes are used to distinguish medications or devices within a multi component or multi medications item e.g., Ingredient(s) plus Strength(s)
No of Identical Medicine Containers or Devices C1			1			For medicines: The number of times the same container type appears in the packaged product.
			C1D1 Component 1			C - Component D - Detail
Medicine/Device Unit Name (C1D1 – C1D3)			Re-usable Tube			Used to distinguish medications or devices within a multi component or multi medications item.
Unit of Use GTIN (C1D1 – C1D3)			Product Specific Application			There may be multiple components to the actual product which may be intended for individual issue at point of use. If available, the unit of use GTIN should be provided if available.
Countable Items (C1D1 – C1D3)			1			Where Healthcare Component Type is M - Medicine or D – Device, there must be at least 1 component detail for the base unit.
Healthcare Component Type C2			D (Device)
No of Identical Medicine Containers or Devices C2			1
			C2D1 Component			C - Component D - Detail
Medicine/Device unit name (C1D1 – C1D3)			High Precision Sterilant Specific Indicators
Unit of Use GTIN (C1D1 – C1D3)			Product Specific Application
Countable Items (C1D1 – C1D3)			250

Referenced Trade Item Type Code			EQUIVALENT			This attribute may be used to capture a replacement, substitute, primary Alternative or equivalent medicine or device (Code List)
Referenced Trade Item GTIN			09312380000XXX

Declarations include Dangerous Goods information, Flashpoint temperature, Global Harmonised System Information to indicate the substances or devices that maybe dangerous to people, property, or the environment. For this example, this information doesn’t need to be captured as it is not applicable.
 

Is Trade Item a Dangerous Good			No			(Code List)
Is Trade Item a Hazardous Good			No			Hazardous goods are chemicals or chemical compounds that are hazardous to humans and environment. (Code List). E.g., Substances that may cause Shock sensitivity, Corrosiveness, Oxidising properties. Etc
Class of Dangerous Goods			Product Specific Application			The “Class" number explains, in general terms, the nature and properties of the goods and classifies them by significant risk. There are approximately 9 danger classes; some classes are further subdivided into subclasses. Please see: United Nations Recommendation on Transport of Dangerous Goods for the Class of Dangerous Goods number.
Class of Dangerous Goods Subsidiary Code			Product Specific Application			Allows a second Class of Dangerous Goods to be recorded in the system.
Dangerous Goods Hazardous Code			Product Specific Application			Dangerous goods hazard ID number must be applied to the vehicle when transporting this trade item by road or rail, to inform the police, the fire brigade, and others about the kind of danger that the cargo can cause in an accident.
Dangerous Goods Packing Group			Product Specific Application			Degree of risk the dangerous goods present during transport according to IATA/IMDG/ADR/RID regulations.
Dangerous Goods Regulation Code			Product Specific Application			Code indicating the classification system(s) of dangerous goods or the Agency (or agencies) responsible for it. (Code list).
Dangerous Goods Shipping Name			Product Specific Application			Shipping name of the trade item (dangerous goods). The recognized agencies, in their regulations, provide a list of all acceptable shipping names. E.g., Flammable Liquid.
Dangerous Goods Technical Name			Product Specific Application			Chemical term of the trade item as listed in the substance list of GGVS (Dangerous Goods Ordinance for Roads) or GGVE (Dangerous Goods Ordinance for Rail).
United Nations Dangerous Goods Number			Product Specific Application			The four-digit number assigned by the United Nations Committee of Experts on the Transport of Dangerous Goods. E.g.  1155 - (DIETHYL ETHER (ETHYL ETHER)). Please see: United Nations Recommendation on Transport of Dangerous Goods for class.
Flash Point Temperature + UOM			Product Specific Application			The lowest temperature at which the substance gives off a sufficient vapour to support combustion.

Referenced File Type Code			SAFETY_DATA_SHEET			Code used to define the type of file being specified in Uniform Resource Identifier. (Code List)
Uniform Resource Identifier			<URL to the Document>

GHS Signal Words Code			NOT_APPLICABLE			To Look up information on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS), please refer to the link. Words such as ‘Danger’ or ‘Warning’ used to emphasize hazards and indicate the relative level of severity of the hazard. (Code List)
GHS Symbol Description Code			NO_PICTOGRAM (Not applicable)			A code depicting the symbols which convey health, physical and environmental hazard information (pictograms) (Code List)
Hazard Statement Code ‘AND’  Hazard Statement Description			Product Specific Application			Standard phrases assigned to a hazard class and category (Code List)
Precautionary Statements Code, ‘AND’ Precautionary Statements Description			Product Specific Application			E.g., H370i - Causes damage to organs if inhaled.
GHS Hazard Category			Product Specific Application			Measures listed on a hazardous label to minimise or prevent adverse effects. E.g., P251 - Do not pierce or burn, even after use.

Does Trade Item Contain DEHP			No			An indicator if Diethylhexyl phthalate (DEHP) is found in the product.
Does Trade Item Contain Latex			No			An indicator if Latex is found in the product.
Manufacturer Declared Reusability Type			SINGLE_USE			Determines if the product is intended for single or multiple uses (code list)
MRI Compatibility			N/A for medical devices			Not required for medicines

Prostheses Rebate Code

Product Specific Application

Rebate codes provided by the department of health when patients are fitted with prostheses or related products. For more information on the code list please refer to the Department of Health.

Additional Trade Item Identification Type Code = "ARTG_ID"			ARTG_ID
Additional Trade Item Identification Type Code > Value			126989			The numeric identifier (ARTG ID) that is allocated to the product by the Australian Therapeutic Goods Administration for a registered or listed product. For more information on the ARTG ID, please visit the Therapeutic Goods Administration Webpage.
Additional Trade Item Classification System Code = "51"			51
Additional Trade Item Classification Code Value						The code assigned to a product that reflects its Poison Schedule.
TGA Type						A flag to indicate whether a product is registered or listed with the Therapeutic Goods Administration (Code list)
TGA Risk Classification			Product Specific Application			A category used to gauge the level of potential harm that a patient could experience by using a medical device. (Code list)
TGA Sponsor			Y			A flag to indicate whether the company associated with this catalogue is the registered TGA Sponsor.
Party Role Code = "REGISTERED_AGENT"			Product Specific Application			Required when the entry for "TGA Sponsor" = No.
Party Name			Product Specific Application			The actual TGA Sponsor’s name, where the company associated with this catalogue is not the TGA sponsor.

Trade Item Feature Code			Product Specific Application
Referenced File Type Code = "IFU"			IFU			This attribute is used for linking assets like documents, images etc to the product data (IFU = Instruction for Use
Uniform Resource Identifier			<URL to Instructions for Use>
Referenced File Type Code = "PRODUCT_IMAGE"			PRODUCT_IMAGE			This attribute is used for linking assets like documents, images etc to the product data
Uniform Resource Identifier			<URL to your product image or if using GS1 Imaging services>
Referenced File Type Code = "VIDEO"			VIDEO
Uniform Resource Identifier			<URL to your Video>
Warranty Description			<Company name> will, at its option either repair or replace any defective Goods or parts thereof with a new or remanufactured equivalent during the Warranty Period at no charge to the Purchaser for parts or labour.			Short text summary of the product warranty.
Warranty Duration + UOM			12 (MON – Months)			The time-period in which the warranty is valid. (Code List)
Warranty Effective Date Type			DATE_OF_LEGAL_WARRANTY_EXPIRATION			The type of date associated with the warranty trade item usually expressed as an event date for the item for example date of purchase, date of manufacture or date of delivery. (Code List)
Suggested Retail Price -> Trade Item Price			330.00			Price as suggested by the manufacturer to end consumer, may or may not appear on packaging
Suggested Retail Price -> Price Basis Quantity + UOM			EA
Suggested Retail Price -> Trade Item Price -> Currency Code			AUD – Australian, Dollars
Suggested Retail Price -> Price Effective End Date
Suggested Retail Price -> Price Effective Start Date			2020-01-01

Communication Channel Code			EMAIL			Code specifying the type of communication channel, for example TELEPHONE.
Communication Value			GS1@GS1Australia.org			Text identifying the endpoint for the communication channel, for example a telephone number, e-mail address or website URL.
Contact Name
Contact Type Code