Preferred Label : Device Labeler;
NCIt related terms : Labeler;
NCIt definition : An individual that labels a device.;
Alternative definition : FDA: Any person who causes a label to be applied to a device with the intent that
the device will be introduced into interstate commerce without any intended subsequent
replacement or modification of the label; and any person who causes the label of a
device to be modified with the intent that the device will be introduced into interstate
commerce without any subsequent replacement or modification of the label, except that
the addition of the name of, and contact information for, a person who distributes
the device, without making any other changes to the label, is not a modification for
the purposes of determining whether a person is a labeler. Per 21 CFR 801.3.;
Origin ID : C101684;
UMLS CUI : C3640172;
Automatic exact mappings (from CISMeF team)
- labeling [Artificial nutrition thesaurus concept]
- labeling [Blood Transfusion thesaurus concept]
- Semantic type(s)
- concept_is_in_subset
