01112

Product Evaluation Status

2013-03-10
Definition: This field identifies the status of product evaluation. Subpart A Item H.3 of the Coding Manual for FDA Form 3500A may also be used. If no codes are available, text may be sent in the second component of the field. Refer to HL7 Table 0247 - Status of Evaluation for valid values.
LengthNot specified
12 values
AEvaluation anticipated, but not yet begun
CProduct received in condition which made analysis impossible
DProduct discarded -- unable to follow up
IProduct remains implanted -- unable to follow up
KProblem already known, no evaluation necessary
OOther
PEvaluation in progress
QProduct under quarantine -- unable to follow up
RProduct under recall/corrective action
UProduct unavailable for follow up investigation
XProduct not made by company
YEvaluation completed
22 components
1O-Identifier
2O-Text
3CName of Coding System
4O-Alternate Identifier
5O-Alternate Text
6CName of Alternate Coding System
7C-Coding System Version ID
8O-Alternate Coding System Version ID
9O-Original Text
10O-Second Alternate Identifier
11O-Second Alternate Text
12CName of Second Alternate Coding System
13O-Second Alternate Coding System Version ID
14C-Coding System OID
15O-Value Set OID
16C-Value Set Version ID
17C-Alternate Coding System OID
18O-Alternate Value Set OID
19C-Alternate Value Set Version ID
20C-Second Alternate Coding System OID
21O-Second Alternate Value Set OID
22C-Second Alternate Value Set Version ID