4 results
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13ms
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Sources: EU EUDAMED, US FDA
OPEN HEART TRAY PACK A CONTENTS: (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE LIF (1) MAYO STAND COVER REINFORCED L/F (3) TOWEL ABSORBENT 15" X 20" LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) SPLIT SHEET BILATERAL 84" X 80" (12) % SHEET 60" X 77" DRAPE REINFORCED LIF (1) MAYO TRAY LARGE (1) CV DRAPE SPLIT CARDIO WITH CLEAR ANEST. SC STD SMS (15) TOWELS CLOTH HUCK BLUE (4) TOWELS CLOTH HUCK WHITE (2) STOCKINETTE IMPERVIOUS 14" X 48" LIF (30) LAP SPONGE PREWASH 18" X 18" XRD LIF (1) WRAPPER 54" X 54" (3) LITES GLOVE LIF OPEN HEART TRAY HOSPITAL HERMANOS MELENDEZ PACKB CONTENTS: (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE LIF (1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL (2) CATHETER THORACIC 32FR. STRAIGH (2) PENCIL CAUTERY ROCKER SWITCH LIF (3) TUBE SUCTION CONNECT W X 12' LIF (2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) LABEL SET, HEPARINE SALINE (2) CAUTERY TIP POLISHER LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) BANDAGE ELASTIC 6" X 5yds LIF (2) YANKAUER SUCTION TUBE WITHOUT VENT LIF (2) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (1) NEEDLE HYPODERMIC 25G X 5/8 ST. (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) NEEDLE HYPODERMIC 27G X %" ST. (1) NEEDLE & BLADE COUNTER 60C MAG/MAG (2) BOWL UTILITY 16oz. (4) FEEDING TUBE 8FR, 15" LONG (2) BULB SYRINGE 60cc (1) TRAY PLATFORM LARGE (1) SKIN MARKER WITH RULER (1) CATHETER 18FR SUCTION W/STRA LIF (1) WRAPPER 54" X 54" UF (1) BLADE SURGICAL #10 CARBON STEEL (1) BLADE SURGICAL #15 CARBON STEEL (2) BLADE SURGICAL #11 CARBON STEEL (1) BLADE SURGICAL #20 CARBON STEEL OPEN HEART TRAY HOSPITAL HERMANOS MELENDEZ PACKC CONTENTS: (9) TOWELS ABSORBENT 15" X 20" UF (6) GOWN FAB REINFORCED SONTARA X-LARGE (1) GOWN IMPERVIOUS XTRA REINFORCED X-LARGE TOWEL & WRAP LEVEL Ill (1) TABLE COVER REINFORCED 44" X 78" UF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
OPEN HEART TRAY - - PACK A ( 1) CV SPLIT DRAPE W/ CLEAR AN EST SCREEN STD SMS LIF (5) DRAPE % ECONOMY 53" X 77" LIF ( 1) MAYO STAND COVER REINFORCED LIF (7) DRAPE UTILITY WITH TAPE L/F (8) HUCK CLOTH TOWELS WHITE L/F (20) HUCK CLOTH TOWELS BLUE LIF (1) MAYO TRAY LARGE LIF (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE LIF (6) 3/4 SHEET DRAPE REINFORCED LIF (2) STOCKINETTE 9" X 48" LIF (1) SPLIT SHEET BILATERAL 84" X 80" LIF (3) DRAPE SHEET 41" X 58" SMS LIF (4) Pr. GLOVES SURGEON #7 BIOGEL OPEN HEART TRAY - HOSPITAL DAMAS - PACK B- (1) PLASTIC RULER 12" LONG (2) SYRINGE 60ML WITHOUT NEEDLE LISLIP L/F (1) Pk. PEANUT SPONGE DISSECTOR ST. (2) UTILITY BOWL 32 oz. LIF (1) SKIN MARKER WITH RULER LIF (2) UTILITY BOWL 16 oz. UF (3) BULB SYRINGE 60cc UF (1) MAYO TRAY SMALL L/F (2) YANKAUER SUCT. TUBE WITHOUT VENT UF (1) TRAY ORGANIZER FULL DEEP LIF (5) SAPHENOUS VEIN CANNULA LIF (40) LAP SPONGES PRE-WASH XRD UF (2) ELASTIC BANDAGE 6" X 5 yds. UF (2) SUTURE BAG FLORAL (2) NEEDLE & BLADE COUNTER 40c FOAM/MAG UF (1) BLADE SHARP ALL ARROUND 69 (1) SURGICAL BLADE# 11 CARBON STEEL (4) LITE GLOVES UF (2) SURGICAL BLADE# 15 CARBON STEEL (1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL (1) SYRINGE 1 cc TUBER 25G X 5/8 S/TIP LIF (2) POUCH INSTRUMENT (2) SURGICAL BLADE# 10 CARBON STEEL (30) GAUZE SPONGES 4" X 4" 16 PLY XRD UF (2) CAUTERY PENCIL ROCKER SWITCH LIF (2) POLISHER CAUTERY TIP UF (1) LABEL SET, HEPARINE,SALINE (2) ELASTIC BANDAGE 4" X 5 yds. LIF (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE UF (1) NEEDLE HYPODERMIC 18G X 1% LIF (2) COTION GLOVE HEAVY DUTY (1) AORTIC MONITORING PRESS SET 5.0 (1) CONNECTOR Y 3/8" X 3/8" X 3/8" LIF (2) NEEDLE HYPODERMIC 22G X 1 % LIF (1) BLADE 6.1 X 32.3 X 1.0MM (1) SQUARE TWO PIECE 500cc GRADUATE (2) CONNECTOR REDUCER (1) NEEDLE BLADE/KNIFE 3.0MM EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
Alaris Infusion Pump administration sets labeled as: -Infusion Set Alaris Pump Module/Medley Pump Module/Gemini Infusion Pump, REF 10011301, CareFusion, WARNING: TO PREVENT FREE-FLOW, CLOSE SET CLAMP WHEN SAFETY CLAMP FITMENT ON PUMP SEGMENT IS OPEN, Fluid path is STERILE and NONPYROGENIC. 12276678 Rev 00 -VersaSafe Infusion Set Alaris Pump Module/Medley Pump Module/Gemini Infusion Pump, REF 2120-0500, WARNING: TO PREVENT FREE-FLOW, CLOSE SET CLAMP WHEN SAFETY CLAMP ON PUMP SEGMENT IS OPEN. FLUID PATH IS STERILE and NON-PYROGENIC. PRODUCT is sterilized by GAMMA IRRADIATION. CareFusion, 630-01104 Rev 00 -SmartSite Infusion Set Alaris Pump Module/Medley Pump Module/Gemini Infusion Pump REF 2420-0500,WARNING: TO PREVENT FREE-FLOW, CLOSE SET CLAMP WHEN SAFETY CLAMP ON PUMP SEGMENT IS OPEN. FLUID PATH IS STERILE and NON-PYROGENIC. PRODUCT is sterilized by GAMMA IRRADIATION. CareFusion, 630-00952 Rev 01 -Infusion Set Alaris Pump Module/Medley Pump Module REF 24009-0007T, WARNING: TO PREVENT FREE-FLOW, CLOSE SET CLAMP WHEN SAFETY CLAMP ON PUMP SEGMENT IS OPEN, FLUID PATH IS STERILE and NON-PYROGENIC. PRODUCT is sterilized by GAMMA IRRADIATION. CareFusion 630-00650 Rev 00 Production Usage: Administration sets allow for the intravenous administration of fluids, medications, nutritional support and transfusion therapy through a needle or catheter inserted into the patient s artery or vein. The sets are comprised with components commonly found on intravascular administration sets and extension sets. The components include an Alaris Pump module silicone segment and fitments, drip chamber, check valve, one or more SmartSite needleless connectors, slide clamp, male luer with spin lock and tubing with different length of tubing.
FDA Enforcement
Class II
·Terminated·CareFusion 303, Inc.·November 14, 2018
BioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provide accuracy in marking a biopsy location for visualization during surgical resection.
FDA Enforcement
Class II
·Terminated·Surgical Specialties Mexico S DE RL DE CV·October 19, 2016