ICU MEDICAL, INC. 460900407 Transpac™

The Stat Profile Prime Plus Blood Analyzer is a compact, whole blood critical care analyzer that provides rapid and comprehensive results. It measures blood gases, electrolytes, metabolites, and co-oximetry, delivering 32 calculated results. Featuring maintenance-free, replaceable cartridge technology and patented non-lysing co-oximetry, the analyzer produces a complete test panel in about one minute. It also offers bidirectional connectivity and a powerful onboard data management system for efficient data handling and integration

Brush & Micro Tips Kit, 100 Brush Tips & 5 Handles

Sunquest Laboratory is intended for use by professionals working in a clinical laboratory.Sunquest Laboratory is intended for use only by professionals who have received extensivetraining in the use of the software. Sunquest Laboratory is controlled via user defined securitylevels, which allow the laboratories to manage data security and integrity. The system is marketed as an automated solution for managing laboratory processes, including:• Patient registration• Order entry and order modification• Specimen collection, verification, suitability, and distribution• Quality assurance checking• Workload recording• Billing charge capture• Standards and controls recording• Test order result inquiry and reporting• Organism susceptibility and epidemiology records• Microbiology culture direct examination and observation recording• Outreach clients, specimens, and results• Client-specific reporting capabilities• Inbound client service request tracking• Historical data

Sunquest Laboratory is intended for use by professionals working in a clinical laboratory.Sunquest Laboratory is intended for use only by professionals who have received extensivetraining in the use of the software. Sunquest Laboratory is controlled via user defined securitylevels, which allow the laboratories to manage data security and integrity. The system is marketed as an automated solution for managing laboratory processes, including:• Patient registration• Order entry and order modification• Specimen collection, verification, suitability, and distribution• Quality assurance checking• Workload recording• Billing charge capture• Standards and controls recording• Test order result inquiry and reporting• Organism susceptibility and epidemiology records• Microbiology culture direct examination and observation recording• Outreach clients, specimens, and results• Client-specific reporting capabilities• Inbound client service request tracking• Historical data

CATH MPAC STP 6F

CATH TEMPO 4F STR 65CM 5SH

CATH MPAC 4F JL4,JR4,PIG 6/110

First Aid Kit Wihout Drug (Content : Adhesive bandages in a variety of different sizes and shapes + Non-adherent sterile Gauze Pad + Cleansing wipe (with alcohol)) This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

The Test of Variables of Attention (T.O.V.A.) kit contains the hardware and software necessary to install and administer the T.O.V.A. continuous performance test. The T.O.V.A. provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.

The Stat Profile Prime Plus Blood Analyzer is a compact, whole blood critical care analyzer that provides rapid and comprehensive results. It measures blood gases, electrolytes, metabolites, and co-oximetry, delivering 32 calculated results. Featuring maintenance-free, replaceable cartridge technology and patented non-lysing co-oximetry, the analyzer produces a complete test panel in about one minute. It also offers bidirectional connectivity and a powerful onboard data management system for efficient data handling and integration

Brush & Micro Tips Kit, 100 Brush Tips & 5 Handles

Sunquest Laboratory is intended for use by professionals working in a clinical laboratory.Sunquest Laboratory is intended for use only by professionals who have received extensivetraining in the use of the software. Sunquest Laboratory is controlled via user defined securitylevels, which allow the laboratories to manage data security and integrity. The system is marketed as an automated solution for managing laboratory processes, including:• Patient registration• Order entry and order modification• Specimen collection, verification, suitability, and distribution• Quality assurance checking• Workload recording• Billing charge capture• Standards and controls recording• Test order result inquiry and reporting• Organism susceptibility and epidemiology records• Microbiology culture direct examination and observation recording• Outreach clients, specimens, and results• Client-specific reporting capabilities• Inbound client service request tracking• Historical data

Sunquest Laboratory is intended for use by professionals working in a clinical laboratory.Sunquest Laboratory is intended for use only by professionals who have received extensivetraining in the use of the software. Sunquest Laboratory is controlled via user defined securitylevels, which allow the laboratories to manage data security and integrity. The system is marketed as an automated solution for managing laboratory processes, including:• Patient registration• Order entry and order modification• Specimen collection, verification, suitability, and distribution• Quality assurance checking• Workload recording• Billing charge capture• Standards and controls recording• Test order result inquiry and reporting• Organism susceptibility and epidemiology records• Microbiology culture direct examination and observation recording• Outreach clients, specimens, and results• Client-specific reporting capabilities• Inbound client service request tracking• Historical data