For each type of model, the UDI device identifier and the issuing agency's name must be entered in the Australian Unique Device Identification Database, together with the packaging identifier for each packaging type used, within 30 days from the first supply for use in Australia on or after the general start day (for packaging, the first supply in that packaging). The entry must also carry the TGA manufacturer identification number, manufacturer name, brand name, device number, model or version number, additional identifiers, handling and storage needs, warnings and precautions, special operating instructions, single-use status and any reuse limit, sterilisation method, whether lot or serial number and manufacture or expiry date are provided, whether a blood donation identification number can be given, whether it is or includes software, whether it is a kit, the base package quantity and, where clinical size type is entered, its value and unit. A change such as becoming single use, latex content, MRI safety status, sterile packaging or sterilise-before-use, clinical size, fewer recommended reuses, brand name, model or version, package quantity or a software feature change affecting safety, performance or purpose creates a new model needing its own device identifier. Information in the database must be accurate and up to date.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.