Device Description : Amia Automated PD System is intended for automatic control of dialysate solution Amia Automated PD System is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing peritoneal dialysis
Device Class : 2
Duns Number: 005146311
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library provides delive The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library provides delivery of fluids in a controlled manner. It is a software controlled electromechanical device used for infusion of pharmaceutical drugs, blood, blood products and mixtures of patient therapy through administration sets.
Device Class : 2
Duns Number: 079209157
Premarket Exempt : No
Prescription Use : Yes
Device Description : Sharesourece is a web-based connectivity platform that allows authorized users, Sharesourece is a web-based connectivity platform that allows authorized users, including nephrologists, clinicians, and nurses in the dialysis center, to remotely view and manage treatment information sent from the Amia APD System.
Device Class : 2
Duns Number: 005146311
Premarket Exempt : No
Prescription Use : Yes
Device Description : Solution Set, Male Epidural Non-Luer Lock Adapter For Epidural Use
Device Class : 2
Duns Number: 005146311
Premarket Exempt : No
Prescription Use : Yes
Device Description : Non-DEHP IV Fat Emulsion Administration Set, Male Luer Lock Adapter with Retract Non-DEHP IV Fat Emulsion Administration Set, Male Luer Lock Adapter with Retractable Collar
Device Class : 2
Duns Number: 005146311
Premarket Exempt : No
Prescription Use : Yes
Device Description : Solution Set with DUO-VENT Spike, Polyethylene Lined Tubing, Non-DEHP Pump Segme Solution Set with DUO-VENT Spike, Polyethylene Lined Tubing, Non-DEHP Pump Segment, Luer Activated Valve, Male Luer Lock Adapter, 117" 2.6m approx., 10 drops/mL approx.
Device Class : 2
Duns Number: 005146311
Premarket Exempt : No
Prescription Use : Yes
Device Description : Non-DEHP CONTINU-FLO Solution Set, 68" 1.7m approx., 2 Luer Activated Valves, Ma Non-DEHP CONTINU-FLO Solution Set, 68" 1.7m approx., 2 Luer Activated Valves, Male Luer Lock Adapter with Retractable Collar, Non-DEHP Large Bore Stopcock Extension Set, 59" 1.5m, 8.7 mL approx., Large Bore Stopcock Manifold, Luer Activated Valve, Male Luer Lock Adapter with Retractable Collar, 10 drops/mL approx.
Device Class : 2
Duns Number: 005146311
Premarket Exempt : No
Prescription Use : Yes
Device Description : Non-DEHP Solution Set, 1.2 Micron Downstream Filter, Luer Activated Valve, Male Non-DEHP Solution Set, 1.2 Micron Downstream Filter, Luer Activated Valve, Male Luer Lock Adapter with Retractable Collar, 107" 2.7m approx., 10 drops/mL approx.
Device Class : 2
Duns Number: 005146311
Premarket Exempt : No
Prescription Use : Yes
Device Description : Non-DEHP CONTINU-FLO Solution Set, 2 Luer Activated Valves, Male Luer Lock Adapt Non-DEHP CONTINU-FLO Solution Set, 2 Luer Activated Valves, Male Luer Lock Adapter with Retractable Collar, 96" 2.4m approx., 10 drops/mL approx.
Device Class : 2
Duns Number: 005146311
Premarket Exempt : No
Prescription Use : Yes
Device Description : Non-DEHP CONTINU-FLO Solution Set, 3 Luer Activated Valves, Male Luer Lock Adapt Non-DEHP CONTINU-FLO Solution Set, 3 Luer Activated Valves, Male Luer Lock Adapter with Retractable Collar, 117" 2.7m approx., 60 drops/mL approx.
Device Class : 2
Duns Number: 005146311
Premarket Exempt : No
Prescription Use : Yes