Figure 7-24. PDC attributes
SEQ |
LEN |
DT |
OPT |
RP/ # |
TBL # |
ITEM # |
ELEMENT NAME |
1 |
80 |
XON |
R |
01247 |
Manufacturer/Distributor |
||
2 |
60 |
CE |
R |
01248 |
Country |
||
3 |
60 |
ST |
R |
01249 |
Brand Name |
||
4 |
60 |
ST |
O |
01250 |
Device Family Name |
||
5 |
60 |
CE |
O |
01251 |
Generic Name |
||
6 |
60 |
ST |
O |
Y |
01252 |
Model Identifier |
|
7 |
60 |
ST |
O |
01253 |
Catalogue Identifier |
||
8 |
60 |
ST |
O |
Y |
01254 |
Other Identifier |
|
9 |
60 |
CE |
O |
01255 |
Product Code |
||
10 |
4 |
ID |
O |
0330 |
01256 |
Marketing Basis |
|
11 |
60 |
ST |
O |
01257 |
Marketing Approval ID |
||
12 |
12 |
CQ |
O |
01258 |
Labeled Shelf Life |
||
13 |
12 |
CQ |
O |
01259 |
Expected Shelf Life |
||
14 |
26 |
TS |
O |
01260 |
Date First Marked |
||
15 |
26 |
TS |
O |
01261 |
Date Last Marked |
7.11.5.0 PDC field definitions
Components: <organization name (ST)>^ <organization name type code (IS)> ^<ID Number (NM)> ^ <check digit (NM)> ^ <code identifying the check digit scheme employed (ID)> ^ <assigning authority (HD)> ^ <identifier type code (IS)> ^ <assigning facility ID (HD)>
Subcomponents of assigning authority: <namespace ID (IS)> & <universal ID (ST)> * <universal ID type (ID)>
Subcomponents of assigning facility: <namespace ID (IS)> & <universal ID (ST)> * <universal ID type (ID)>
Definition: This field contains the identity of the manufacturer/distributor.
Components: <identifier (ST)> ^ <text (ST)> ^ <name of coding system (ST)> ^ <alternate identifier (ST)> ^ <alternate text (ST)> ^ <name of alternate coding system (ST)>
Definition: This field contains the country to which this product detail is relevant. ISO 3166 provides a list of country codes that may be used.
Definition: This field contains the name under which the product is marketed by this manufacturer.
Definition: This field contains the name used by the manufacturer to describe the family of products to which this product belongs.
Components: <identifier (ST)> ^ <text (ST)> ^ <name of coding system (ST)> ^ <alternate identifier (ST)> ^ <alternate text (ST)> ^ <name of alternate coding system (ST)>
Definition: This field contains the name generically used to identify the product.
Definition: This field contains the manufacturers model identifier for the product.
Definition: This field contains the manufacturers catalogue identifier for the product.
Definition: This field contains any other identifier used to for the product.
Components: <identifier (ST)> ^ <text (ST)> ^ <name of coding system (ST)> ^ <alternate identifier (ST)> ^ <alternate text (ST)> ^ <name of alternate coding system (ST)>
Definition: This field contains the product code from an external coding system such as that used by the CDRH at the FDA.
Definition: This field contains the basis for marketing approval. Refer to HL7 table 0330 - Marketing basis for valid values.
Table 0330 - Marketing basis
Value |
Description |
510K |
510 (K) |
510E |
510 (K) exempt |
PMA |
Premarketing authorization |
PRE |
Preamendment |
TXN |
Transitional |
522S |
Post marketing study (522) |
Definition: This field contains the designation or description of the marketing basis.
Components: <quantity> ^ <units>
Definition: This field contains the shelf life of the product as labeled. This will usually be in months or years. If there is no shelf life indicated in the product labeling, this field will be empty.
Components: <quantity> ^ <units>
Definition: This field contains the shelf life of the product expected by the manufacturer. This will usually be in months or years.
Definition: This field contains the date the product was first marketed in the country.
Definition: This field contains the date the product was last marketed in the country. This field will be omitted if the product is still being marketed.