Previous Page TOC Index Next Page

7.11.5 PDC - product detail country segment

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

7.11.5.1 Manufacturer/distributor (XON) 01247

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.

7.11.5.2 Country (CE) 01248

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.

7.11.5.3 Brand name (ST) 01249

Definition: This field contains the name under which the product is marketed by this manufacturer.

7.11.5.4 Device family name (ST) 01250

Definition: This field contains the name used by the manufacturer to describe the family of products to which this product belongs.

7.11.5.5 Generic name (CE) 01251

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.

7.11.5.6 Model identifier (ST) 01252

Definition: This field contains the manufacturer’s model identifier for the product.

7.11.5.7 Catalogue identifier (ST) 01253

Definition: This field contains the manufacturer’s catalogue identifier for the product.

7.11.5.8 Other identifier (ST) 01254

Definition: This field contains any other identifier used to for the product.

7.11.5.9 Product code (CE) 01255

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.

7.11.5.10 Marketing basis (ID) 01256

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)

7.11.5.11 Marketing approval ID (ST) 01257

Definition: This field contains the designation or description of the marketing basis.

7.11.5.12 Labeled shelf life (CQ) 01258

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.

7.11.5.13 Expected shelf life (CQ) 01259

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.

7.11.5.14 Date First Marked (TS) 01260

Definition: This field contains the date the product was first marketed in the country.

7.11.5.15 Date Last Marked (TS) 01261

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.

Previous Page TOC Index Next Page