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.

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

C1D1
Component 1

For medicines: The number of times the same container type appears in the packaged product.

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

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)

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