Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration)

The Codonics Safe Labeling System is a computer-based drug preparation and labeling system used primarily in perioperative and anesthesia settings. It scans drug vial barcodes (NDC/UDI codes), verifies them against a hospital formulary database, and prints waterproof, color-coded labels for prepared medications (syringes, IV bags) with human-readable text, 2D barcodes, and optionally embedded RFID tags. The system provides audible and visual confirmation of drug identity to reduce medication errors during surgical procedures.

The SLS 700i and related 610i, 620i, 630i series add RFID read/write capabilities to the predicate SLS barcode-scanning platform. Key additions include HF and/or UHF RFID controller boards, micro antennae, and software to encode formulary-verified drug information to passive RFID tags embedded in secondary container labels, enabling third-party applications to read medication data. The core barcode scanning, formulary verification, color label printing, and 2D barcode output remain functionally identical to the predicate K101439 device.

ASTM D4774 (drug label color and pattern for anesthesia), ISO 26825:2008/2020 (anesthetic syringe labels), ASTM D4267 (parenteral drug container labels), IEC 60601-1:2005 and IEC 60601-1-2:2014+A1:2020 (medical device electrical safety and EMC), CISPR 11:2015 (radio disturbance limits), FCC Part 15.247 and RSS-247 (RF emissions), Joint Commission NPSG standards, and FDA/ISMP drug labeling guidelines.

The device is substantially equivalent because RFID is presented as an alternative machine-readable format added to the predicate's proven barcode/formulary verification workflow—the NDC barcode remains the documented 'source of truth' for drug identification and label generation. All core safety-critical functions (barcode scanning, formulary confirmation, visual/audible alerts, compliant label printing) are identical to the cleared K101439 predicate. RFID merely encodes the same validated drug information already printed as 2D barcodes and human-readable text; it does not alter the drug identification, verification, or clinical decision-making processes. Extensive testing demonstrates equivalent safety and effectiveness in drug labeling accuracy with no new hazards introduced.