Address:25212 W. ILLINOIS ROUTE 120,ROUND LAKE,IL,60073,US
Device Description : FLOSEAL Hemostatic Matrix, 10mL
Device Class : 3
Duns Number: 628013963
Premarket Exempt : No
Prescription Use : Yes
Device Description : The product is a sterile dialysis solution intended for treatment of acute kidne The product is a sterile dialysis solution intended for treatment of acute kidney disease (renal failure) using Continuous Renal Replacement Therapies, such as continuous hemodialysis and hemodiafiltration aimed at normalizing the composition of the blood. The product may also be used in case of drug poisoning with dialyzable or filterable substances.
Device Class : 2
Duns Number: 005083209
Premarket Exempt : No
Prescription Use : Yes
Device Description : Micro-Volume Extension Set
Device Class : 2
Duns Number: 005083209
Premarket Exempt : No
Prescription Use : Yes
Device Description : Micro-Volume Extension Set with 0.2 m Filter
Device Class : 2
Duns Number: 005083209
Premarket Exempt : No
Prescription Use : Yes
Device Description : Blood Extension Set
Device Class : 2
Duns Number: 005083209
Premarket Exempt : No
Prescription Use : Yes
Device Description : Male Luer Lock Adapter with Retractable Collar
Device Class : 2
Duns Number: 005083209
Premarket Exempt : No
Prescription Use : Yes
Device Description : This device is a plastic disconnect cap for peritoneal dialysis and contains pov This device is a plastic disconnect cap for peritoneal dialysis and contains povidone-iodine intended to protect the female Luer connector of the Baxter transfer set.
Device Class : 2
Duns Number: 005083209
Premarket Exempt : Yes
Prescription Use : Yes
Device Description : Floseal Matrix is indicated in surgical procedures (other than in ophthalmic) as Floseal Matrix is indicated in surgical procedures (other than in ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
Device Class : 3
Duns Number: 628013963
Premarket Exempt : No
Prescription Use : Yes
Device Description : CLEARLINK System. Non-DEHP Solution Set with DUO-VENT Spike
Device Class : 2
Duns Number: 005083209
Premarket Exempt : No
Prescription Use : Yes
Device Description : Micro-Volume Catheter Extension Set with 0.2 micrometer Filter
Device Class : 2
Duns Number: 005083209
Premarket Exempt : No
Prescription Use : Yes