Catalog/Reference (REF), 12, 13, 15, Regulated Entity Information, 63 43 Regulated Entity Name, 67 Contains Biological Material, 85 Regulatory Authorization or Marketing Device Identifier, 13, 15, 47 Number, 13, 14, 16 Kit, 12, 14, 15, 82 Regulatory Information, 99 Lot or Batch Number, 13, 15 Reusable - Multi-Patient Use Device, Manufacturing Date, 13, 15 12, 14, 15, 91 Medical Device Risk Classification, 12, Reusable - Single Patient Use Device, 14, 16 12, 14, 15, 91, 97 Medical Device System, 12, 14, 15 Single Use Device, 12, 14, 15, 87 Medical Device Type, 12, 14, 15, 16 Software or Firmware, 12, 13, 15, 43 Model, 12, 13, 15, 38 Submission Number, 12 Production Identifier, 49 Supplied Sterile, 12, 14, 15, 97 Regulated Entity Identifier, 80 Unique Device Identifier, 13, 15, 45
Catalog/Reference (REF), 12, 13, 15, 43 Contains Biological Material, 85 Device Identifier, 13, 15, 47 Kit, 12, 14, 15, 82 Lot or Batch Number, 13, 15 Manufacturing Date, 13, 15 Medical Device Risk Classification, 12, 14, 16 Medical Device System, 12, 14, 15 Medical Device Type, 12, 14, 15, 16 Model, 12, 13, 15, 38 Production Identifier, 49 Regulated Entity Identifier, 80 Regulated Entity Information, 63 Regulated Entity Name, 67 Regulatory Authorization or Marketing Number, 13, 14, 16 Regulatory Information, 99 Reusable - Multi-Patient Use Device, 12, 14, 15, 91 Reusable - Single Patient Use Device, 12, 14, 15, 91, 97 Single Use Device, 12, 14, 15, 87 Software or Firmware, 12, 13, 15, 43 Submission Number, 12 Supplied Sterile, 12, 14, 15, 97 Unique Device Identifier, 13, 15, 45
imdrf-proc-170316-data-exchange-guidelines.docx