01112

Product Evaluation Status

2007-05-08
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.
Length≤250
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
6 components
1O-Identifier
2O-Text
3OName of Coding System
4O-Alternate Identifier
5O-Alternate Text
6OName of Alternate Coding System