di.xpt (copied v1.0 of medical devices IG) - This example is a copy of Example 1 from di.xpt in SDTMIG-MD v1.0 but with values for SPDEVID and DIVAL revised slightly.
- Should I remove the FDA UDI (row 5) unless CTP has or plans to establish UDI values?
Example 1
This shows records for two three devices where the sponsor felt that the type, manufacturer, model number, and serial number were necessary for unique identification. In addition, there was a post-marketing UDI identifier available for the first device. - Rows 1-5 show the records for a device given a SPDEVID of PUFFMASTER3K
- Rows 5-8 show the records for a device given a SPDEVID of PUFFMASTER2023
- Rows 9-12 show
Row | STUDYID | DOMAIN | SPDEVID | DISEQ | DIPARMCD | DIPARM | DIVAL | 1 | 123 | DI | PUFFMASTER3K | 1 | DEVTYPE | Device Type | ENDS | 2 | 123 | DI | PUFFMASTER3K | 2 | MANUF | Manufacturer | Acme Machines | 3 | 123 | DI | PUFFMASTER3K | 3 | MODEL | Model Number | 45-JFI | 4 | 123 | DI | PUFFMASTER3K | 4 | SERIAL | Serial Number | 456789132-AXQ | 5 | 123 | DI | PUFFMASTER3K | 5 | FDAUDI | FDA Unique Device Identifier | 456789123xyz | 6 | 123 | DI | PUFFMASTER2023 | 1 | DEVTYPE | Device Type | SmokeMachine | 7 | 123 | DI | PUFFMASTER2023 | 2 | MANUF | Manufacturer | Acme Machines | 8 | 123 | DI | PUFFMASTER2023 | 3 | MODEL | Model Number | 62-PLC | 9 | 123 | DI | PUFFMASTER2023 | 4 | SERIAL | Serial Number | 215964564-NFS | 10 | 123 | DI | UsualCTCigarette | 1 | DEVTYPE | Device Type | Combustible Tobacco Cigarette | 11 | 123 | DI | UsualCTCigarette | 2 | MANUF | Manufacturer | Philip Morris International | 12 | 123 | DI | UsualCTCigarette | 3 | MODEL | Model Number | Marlboro Red | 13 | 123 | DI | UsualCTCigarette | 4 | SERIAL | Serial Number | 123456789 |
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