single site or hospital (for example, pediatric versus cardiac).
Additional uses include producing labels for IVs and other artifacts used during a surgical
procedure.
The Codonics SLS is generally placed in, however not limited to, the perioperative
environment to identify syringes prepared for anesthesiology use during surgery.
Typical users of this system are trained professionals, including but not limited to
physicians, nurses, and technicians.
The major characteristics and functions of the family of devices include:
• Scanning the drug container barcode directly from a vial or other type of container
• Decoding the manufacturer-issued barcode into the required FDA National Drug Code
(NDC) or Unique Drug Identifier (UDI) number
• Referring the NDC/UDI number to a site-managed formulary lookup database
• Providing audio and ISO-compliant visual “readback” of the drug name
• Providing an alert if the drug container is listed as “recalled/obsolete” in the site’s
formulary
• Printing an easy-to-read, water resistant ISO 26825 compliant color label meeting The
Joint Commission medication management standards and the American Society of
Anesthesiologists guidelines for labeling
• Providing the basic information by which the printed label barcode can be read to
document medication administration in an AIMS
• Printing labels with insertion and expiration date and time for IV lines
Device Indications for Use Statement: Prescription Use Device
The Codonics SLS PCS device and SLS software provides a simple computer-based barcode
scanning and printing system to automatically verify drug identity from NDC and other drug
container UDI barcodes, and to print labels for prepared drugs and other items in use on
patients during surgical procedures.
The Codonics SLS PCS is generally placed in, however not limited to, the perioperative
environment to identify syringes prepared for anesthesiology use during surgery. Additional
uses include producing labels for IVs and other artifacts used during a surgical procedure. SLS
PCS can also be used to print “non-surgical environment” color and text labels as required.
Typical users of this system are trained professionals, including but not limited to physicians,
nurses, and technicians.
CAUTION Federal law restricts this device to be sold for use by or on the order of a physician.
Hazardous Material Information
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