US · guidance
CMS SOM App. H, Tag V328
ANSI/AAMI RD47:2002/A1:2003 Requirements as Adopted by Reference 42 CFR §
494.50(b)(1)
10.1 Time of labeling
Each hemodialyzer shall be labeled before or at the first use of the device, and the label
shall be updated after each use (see AAMI 10.3).
Interpretive Guidance § 494.50(b)(1)
When a patient is provided a new dialyzer intended for reprocessing, that dialyzer must be
labeled with the patient’s name before or at the first use. Dialyzers that are used without being
labeled with the applicable patient’s name must be discarded.
History
Rev.
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
88e7d603045d30922fbe679703a60ea094330eebf2cbce4ee466b147dde5982c
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